The #1 pregnancy and parenting destination worldwide, today announced its list of the most and least favorite celebrity baby names of 2010. BabyCenter surveyed its audience to see which celebrity baby names made the A-list and which fell short. Based on responses from almost 2,000 moms, BabyCenter found that Mark Wahlberg and his wife, Rhea Durham, did the best job in naming their little girl, Grace Margaret. Also topping the list are new parents Neil Patrick Harris and partner David Burtka, who chose Harper Grace for their daughter's name. Additional favorites include Stella Zavala, daughter of Matt Damon and Luciana Barroso, and Easton Quinn Monroe, son of Jenna and Bodhi Elfman.
"Hollywood headliners know how to keep baby naming interesting, and the rest of us are influenced by their choices – whether we love them or hate them," says Linda Murray, BabyCenter editor-in-chief. "Celebrities are creative people, and we see that reflected in many of their name choices. But they're not all immune to the lure of family traditions, spiritual beliefs, or the sound of a beautiful, classic name."
Top 10 Favorite Celebrity Baby Names
Grace Margaret (Mark Wahlberg & Rhea Durham)
Harper Grace (Neil Patrick Harris & David Burtka)
Aviana Olea (Amy Adams & Darren Legallo)
Olivia Marie (Lance Armstrong & Anna Hansen)
Bryn (Bethenny Frankel & Jason Hoppy)
Eli Benjamin (Rachel Dratch & John Wahl)
Stella Zavala (Matt Damon & Luciana Barroso)
Gia Francesca (Mario Lopez & Courtney Mazza)
Levi James (Sheryl Crow)
Easton Quinn Monroe (Jenna & Bodhi Elfman)
Not all nominees can be winners. According to BabyCenter moms, leading the pack of least favorite celebrity baby names is Buddy Bear Maurice, son of Jamie Oliver and Juliette Norton. Also high on the list is Egypt Daoud, son of singer Alicia Keys and her new husband Kaseem Dean, aka Swizz Beatz. Those aren't the only names that moms aren't big fans of. Axel, son of Will Ferrell and Viveca Paulin, and Billie Beatrice, daughter of Eric Dane and Rebecca Gayheart, also made the list of least favorite celebrity baby names.
Top 10 Least Favorite Celebrity Baby Names
Buddy Bear Maurice (Jamie Oliver & Juliette Norton)
Egypt Daoud (Alicia Keys & Kaseem Dean, aka Swizz Beatz)
Cosima Violet (Claudia Schiffer & Matthew Vaughn)
Axel (Will Ferrell & Viveca Paulin)
Krishna Thea (Padma Lakshmi)
Gideon Scott (Neil Patrick Harris & David Burtka)
Billie Beatrice (Eric Dane & Rebecca Gayheart)
Abel James (Amy Poehler & Will Arnett)
Vida (Matthew McConaughey & Camila Alves)
Nelson (Celine Dion & Rene Angelil)
So how do celebrities come up with names for their children? BabyCenter's "Moms and the City" team caught up with some of our favorite celebrities to find out exactly where they got their baby name inspiration. For answers from Brad Pitt, Matt Damon, Mario Lopez, Tina Fey, and other stars, check out the video at www.babycenter.com/celebrities-talk-baby-names.
Saturday, January 22, 2011
Regulatory update - GSK and Valeant receive positive opinion in Europe from the CHMP for Trobalt (retigabine)
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt™(retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.
Retigabine received a preliminary approval from the Swiss Agency for Therapeutic Products, Swissmedic, in December 2010.
Retigabine, referred to as ezogabine in the US, is being jointly developed by GSK and Valeant.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Retigabine received a preliminary approval from the Swiss Agency for Therapeutic Products, Swissmedic, in December 2010.
Retigabine, referred to as ezogabine in the US, is being jointly developed by GSK and Valeant.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Monday, October 4, 2010
Lilly Recognized by the National Hispanic Council on Aging for Ongoing Commitment to the Health of Older Adults
Eli Lilly and Company was given the President's Award by the National Hispanic Council on Aging (NHCOA) at its annual conference in Washington, D.C.
Lilly has developed a successful partnership with the NHCOA to address specific issues facing the aging Hispanic community, such as disparities that exist in the diagnosis of chronic disease.
"The National Hispanic Council on Aging's leadership is proud to honor Lilly with the 2010 President's Award, recognizing the company's commitment to improving the wellbeing of its target audience - especially older adults," said Dr. Yanira Cruz, president & CEO of the NHCOA. "Lilly's philanthropic commitment should serve as an example in the pharmaceutical industry. We applaud Lilly's innovation in addressing key health issues impacting older adults such as diabetes, mental health and Alzheimer's disease."
As part of Lilly's commitment to overcoming health disparities, the company is working to increase Hispanic representation in clinical trials. In the United States, minority populations have historically and consistently been under-represented in clinical trials, which evaluate the safety and efficacy of new medicines and treatments. As part of Lilly's clinical diversity strategy, Lilly is identifying and investing in new relationships with clinical investigators who are likely to treat more diverse patients. As a result, more than 83 new clinical trial sites have been introduced in communities of color since May 2008.
Currently, Lilly and NHCOA are working together to develop initiatives designed to promote diabetes prevention and improve diabetes management among Hispanic older adults and their families through the development of culturally--and linguistically--appropriate and age-sensitive educational efforts. This program aims to reduce the significant disparities that exist between Hispanic and non-Hispanic adults in the United States.
"Lilly and the Council both see the value of promoting better health for our older citizens, and we're pleased that our work has been recognized with this award," said Shaun Hawkins, chief diversity officer at Lilly. "Our commitment to engage, educate and empower patients to take control of their own health becomes even more important when we are working with populations that do not have access to the resources they need to become healthier. Our partnership with NHCOA helps make that connection for patients."
Additional outreach initiatives are conducted by the Organization of Latinos at Lilly, or OLA, an internal employee group. OLA diversity initiatives impact the community, the company and its members by actively supporting the Hispanic/Latino community. For example, OLA members participate in Project Stepping Stone, a community event for Latino high school students from Indiana who are interested in attending college. OLA members also contribute annually to the Hispanic Scholarship Fund organized by USA Funds to help Latino youth access and afford a college education.
Lilly has developed a successful partnership with the NHCOA to address specific issues facing the aging Hispanic community, such as disparities that exist in the diagnosis of chronic disease.
"The National Hispanic Council on Aging's leadership is proud to honor Lilly with the 2010 President's Award, recognizing the company's commitment to improving the wellbeing of its target audience - especially older adults," said Dr. Yanira Cruz, president & CEO of the NHCOA. "Lilly's philanthropic commitment should serve as an example in the pharmaceutical industry. We applaud Lilly's innovation in addressing key health issues impacting older adults such as diabetes, mental health and Alzheimer's disease."
As part of Lilly's commitment to overcoming health disparities, the company is working to increase Hispanic representation in clinical trials. In the United States, minority populations have historically and consistently been under-represented in clinical trials, which evaluate the safety and efficacy of new medicines and treatments. As part of Lilly's clinical diversity strategy, Lilly is identifying and investing in new relationships with clinical investigators who are likely to treat more diverse patients. As a result, more than 83 new clinical trial sites have been introduced in communities of color since May 2008.
Currently, Lilly and NHCOA are working together to develop initiatives designed to promote diabetes prevention and improve diabetes management among Hispanic older adults and their families through the development of culturally--and linguistically--appropriate and age-sensitive educational efforts. This program aims to reduce the significant disparities that exist between Hispanic and non-Hispanic adults in the United States.
"Lilly and the Council both see the value of promoting better health for our older citizens, and we're pleased that our work has been recognized with this award," said Shaun Hawkins, chief diversity officer at Lilly. "Our commitment to engage, educate and empower patients to take control of their own health becomes even more important when we are working with populations that do not have access to the resources they need to become healthier. Our partnership with NHCOA helps make that connection for patients."
Additional outreach initiatives are conducted by the Organization of Latinos at Lilly, or OLA, an internal employee group. OLA diversity initiatives impact the community, the company and its members by actively supporting the Hispanic/Latino community. For example, OLA members participate in Project Stepping Stone, a community event for Latino high school students from Indiana who are interested in attending college. OLA members also contribute annually to the Hispanic Scholarship Fund organized by USA Funds to help Latino youth access and afford a college education.
GSK provides update on Herpevac trial for women evaluating Simplirix™ (Herpes Simplex Vaccine)
GlaxoSmithKline (GSK) has made the decision not to pursue further worldwide development of Simplirix™ (Herpes Simplex Vaccine), an experimental vaccine intended to prevent genital herpes disease in women.
The decision was made following receipt of the results of the Herpevac Trial for Women, a Phase III trial evaluating efficacy of Simplirix™, which was conducted collaboratively with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
The trial began in 2002 and 8,323 women ages 18-30 were vaccinated at 50 sites in the United States and Canada. An assessment of the final trial results showed that the vaccine had an acceptable safety profile, but the primary trial endpoint, prevention of genital herpes disease, was not met. GSK and NIH continue to evaluate data from the trial and plan to present details of the analysis in the near future in an appropriate scientific forum.
Gary Dubin, Vice President and Director, Late Clinical Development at GlaxoSmithKline Biologicals commented: “We would like to express our gratitude towards our partner NIAID for their proactive collaboration and substantial contribution in the program and the volunteers for their participation in the study.”
The decision was made following receipt of the results of the Herpevac Trial for Women, a Phase III trial evaluating efficacy of Simplirix™, which was conducted collaboratively with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
The trial began in 2002 and 8,323 women ages 18-30 were vaccinated at 50 sites in the United States and Canada. An assessment of the final trial results showed that the vaccine had an acceptable safety profile, but the primary trial endpoint, prevention of genital herpes disease, was not met. GSK and NIH continue to evaluate data from the trial and plan to present details of the analysis in the near future in an appropriate scientific forum.
Gary Dubin, Vice President and Director, Late Clinical Development at GlaxoSmithKline Biologicals commented: “We would like to express our gratitude towards our partner NIAID for their proactive collaboration and substantial contribution in the program and the volunteers for their participation in the study.”
Sunday, September 26, 2010
Adding Lantus® to Oral Antidiabetic Drug Therapy Further Reduced Blood Sugar in Patients with Type 2 Diabetes.
Sanofi-aventis announced
results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th
Annual Meeting in Stockholm, Sweden. The first pooled analysis using patient-level data from randomized
clinical trials demonstrated that adding Lantus® (insulin glargine [rDNA] injection) to patients with type 2
diabetes, uncontrolled on oral antidiabetic drug therapy (OADs), was associated with a greater reduction in
A1C levels and lower incidence of any hypoglycemia versus all comparators (OADs, NPH, lispro, premix).
In the second pooled analysis of clinical studies, “patients with type 2 diabetes, who used Lantus® as
monotherapy or added it to one baseline oral antidiabetic agent, demonstrated a greater reduction in A1C
with lower risk of hypoglycemia than those taking two OADs, with a most significant reduction when Lantus®
was added to metformin alone versus other OADs [sulfonylurea alone or sulfonylurea plus metformin],” said
Dr. Jack Leahy of the University of Vermont College of Medicine and principal investigator of one of the
studies.
Better Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus All Comparatorsi
“Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus Competitors” [presentation number
976]: This pooled analysis looked at nine clinical studies where insulin-naïve patients with type 2 diabetes
uncontrolled on OADs were randomized to add Lantus® (n=1,462) or comparators (OADs, NPH, lispro or
premix; n=1,476) to their treatment regimen. Results showed that initiating Lantus® in patients uncontrolled
on OADs was associated with better efficacy and goal attainment overall versus all comparators across the
A1C continuum and when compared to OADs when baseline A1C was ≥8.0 percent.
Outcomes showed:
A1C reductions at week 24 were greater with Lantus® versus all comparators (p<0.001)
Efficacy across A1C categories were similar for insulin comparators
Hypoglycemia rates (any) were lower with Lantus® versus other insulin comparators (Lantus® vs.
NPH, p=0.032, Lantus® vs. lispro, p=<0.001, Lantus® vs. premix, p=004)
Hypoglycemic event rates (any) were higher for Lantus versus OADs (p<0.001), although rates of
severe hypoglycemia were similar between the two groups.
2 / 4
Significant Improvement in A1C Found Independent of Baseline Treatment Regimenii
“Clinical Outcomes after Basal Insulin Initiation Correlate with Baseline Oral Antidiabetic Drug Therapy: A
Pooled Analysis of Clinical Trial Data” [presentation number 960]: This analysis included data from 11
prospective randomized controlled trials of Lantus® with or without OADs in adults with type 2 diabetes. The
analysis compared patients given Lantus® (n=2,171) who were taking zero or one OAD at baseline (low use;
1.8% and 45.2%, respectively) with those taking two OADs (52.2%) and patients on metformin only (8.5%)
with those on sulfonylurea only (36.5%) or metformin and sulfonylurea (49.9%) at baseline.
Outcomes showed:
At week 24, the reduction in A1C was greatest among patients given Lantus® with low baseline OAD
use (0/1 OADs) (p=0.0198) and among those who were taking Lantus® and metformin only
(p=0.0009)
Patients given Lantus® with low baseline OAD use had significantly lower rates of symptomatic
hypoglycemia versus those taking two OADs (p=0.0009)
Patients given Lantus® who were taking only metformin had lower rates of hypoglycemia than those
taking sulfonylurea or metformin plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus
37.5 versus 38.8 U)
Important Safety Information for Lantus®
Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.
You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to
your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision.
Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may
lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include injection site reactions,
including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare
cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and
supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell
your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or
planning to become pregnant, or are breast-feeding or planning to breast-feed.
Indications and Usage
Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children
(6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at
the same time each day to lower blood glucose. Do not use Lantus® to treat diabetic ketoacidosis.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Lantus®, please visit www.Lantus.com or call 800-633-1610.
Important Safety Information for Apidra®
Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you are allergic to any of the
ingredients in Apidra®.
You must test your blood sugar levels while using insulin, such as Apidra®. Do not make any changes to your
dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision. Apidra® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others. Apidra®,
when given by injection under the skin, should not be mixed with insulins other than NPH.
3 / 4
Do not mix Apidra® with any insulin when used in the pump or for intravenous administration.
The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include low blood potassium,
injection site reactions, such as changes in fat tissue at the injection site, and allergic reactions, such as
itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to
insulin, including anaphylactic reactions.
Tell your doctor about other medicines and supplements you are taking because they can change the way
insulin works. Before starting Apidra®, tell your doctor about all your medical conditions including if you have
liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to
breast-feed.
Indications and Usage
Prescription Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1
diabetes to improve blood sugar control. Apidra® is usually used with a longer-acting insulin. When used as a
mealtime insulin, Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal.
Apidra® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Apidra®, please visit www.Apidra.com or call 800-633-1610.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the
hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is
estimated that approximately 285 million adults worldwide are living with the disease and this number is
expected to rise to a staggering 438 million within 20 yearsiii,iv. It is estimated that nearly 24 million Americans
have diabetes, including an estimated 5.7 million who remain undiagnosedv At the same time, according to
NHANES data from 2003-2004, approximately 40 percent of those diagnosed with diabetes did not achieve
the blood sugar control target of A1C <7 percent recommended by the ADAvi. The A1C test measures
average blood glucose levels over the past two-to-three-month period.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people
living with diabetes. The Company currently has insulin products, including Lantus®, Apidra® and Insuman®
(outside the U.S.)-- Lantus® and Apidra® are also available as injection pens (Lantus® SoloSTAR® and
Apidra® SoloSTAR®). Also available in some countries (outside the U.S.) is ClikSTAR®, a reusable insulin
injection pen for Lantus® or Apidra® for people with type 1 or type 2 diabetes. Following the formation of its
Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood
glucose monitoring solutions and the potential first regenerative treatment for diabetes. Investigational
compounds also in the pipeline include the once-daily injectable GLP-1 agonist lixisenatide as a
monotherapy and in combination with basal insulin as well as long-acting insulin analogs.
results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th
Annual Meeting in Stockholm, Sweden. The first pooled analysis using patient-level data from randomized
clinical trials demonstrated that adding Lantus® (insulin glargine [rDNA] injection) to patients with type 2
diabetes, uncontrolled on oral antidiabetic drug therapy (OADs), was associated with a greater reduction in
A1C levels and lower incidence of any hypoglycemia versus all comparators (OADs, NPH, lispro, premix).
In the second pooled analysis of clinical studies, “patients with type 2 diabetes, who used Lantus® as
monotherapy or added it to one baseline oral antidiabetic agent, demonstrated a greater reduction in A1C
with lower risk of hypoglycemia than those taking two OADs, with a most significant reduction when Lantus®
was added to metformin alone versus other OADs [sulfonylurea alone or sulfonylurea plus metformin],” said
Dr. Jack Leahy of the University of Vermont College of Medicine and principal investigator of one of the
studies.
Better Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus All Comparatorsi
“Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus Competitors” [presentation number
976]: This pooled analysis looked at nine clinical studies where insulin-naïve patients with type 2 diabetes
uncontrolled on OADs were randomized to add Lantus® (n=1,462) or comparators (OADs, NPH, lispro or
premix; n=1,476) to their treatment regimen. Results showed that initiating Lantus® in patients uncontrolled
on OADs was associated with better efficacy and goal attainment overall versus all comparators across the
A1C continuum and when compared to OADs when baseline A1C was ≥8.0 percent.
Outcomes showed:
A1C reductions at week 24 were greater with Lantus® versus all comparators (p<0.001)
Efficacy across A1C categories were similar for insulin comparators
Hypoglycemia rates (any) were lower with Lantus® versus other insulin comparators (Lantus® vs.
NPH, p=0.032, Lantus® vs. lispro, p=<0.001, Lantus® vs. premix, p=004)
Hypoglycemic event rates (any) were higher for Lantus versus OADs (p<0.001), although rates of
severe hypoglycemia were similar between the two groups.
2 / 4
Significant Improvement in A1C Found Independent of Baseline Treatment Regimenii
“Clinical Outcomes after Basal Insulin Initiation Correlate with Baseline Oral Antidiabetic Drug Therapy: A
Pooled Analysis of Clinical Trial Data” [presentation number 960]: This analysis included data from 11
prospective randomized controlled trials of Lantus® with or without OADs in adults with type 2 diabetes. The
analysis compared patients given Lantus® (n=2,171) who were taking zero or one OAD at baseline (low use;
1.8% and 45.2%, respectively) with those taking two OADs (52.2%) and patients on metformin only (8.5%)
with those on sulfonylurea only (36.5%) or metformin and sulfonylurea (49.9%) at baseline.
Outcomes showed:
At week 24, the reduction in A1C was greatest among patients given Lantus® with low baseline OAD
use (0/1 OADs) (p=0.0198) and among those who were taking Lantus® and metformin only
(p=0.0009)
Patients given Lantus® with low baseline OAD use had significantly lower rates of symptomatic
hypoglycemia versus those taking two OADs (p=0.0009)
Patients given Lantus® who were taking only metformin had lower rates of hypoglycemia than those
taking sulfonylurea or metformin plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus
37.5 versus 38.8 U)
Important Safety Information for Lantus®
Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.
You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to
your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision.
Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may
lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include injection site reactions,
including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare
cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and
supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell
your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or
planning to become pregnant, or are breast-feeding or planning to breast-feed.
Indications and Usage
Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children
(6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at
the same time each day to lower blood glucose. Do not use Lantus® to treat diabetic ketoacidosis.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Lantus®, please visit www.Lantus.com or call 800-633-1610.
Important Safety Information for Apidra®
Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you are allergic to any of the
ingredients in Apidra®.
You must test your blood sugar levels while using insulin, such as Apidra®. Do not make any changes to your
dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision. Apidra® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others. Apidra®,
when given by injection under the skin, should not be mixed with insulins other than NPH.
3 / 4
Do not mix Apidra® with any insulin when used in the pump or for intravenous administration.
The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include low blood potassium,
injection site reactions, such as changes in fat tissue at the injection site, and allergic reactions, such as
itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to
insulin, including anaphylactic reactions.
Tell your doctor about other medicines and supplements you are taking because they can change the way
insulin works. Before starting Apidra®, tell your doctor about all your medical conditions including if you have
liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to
breast-feed.
Indications and Usage
Prescription Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1
diabetes to improve blood sugar control. Apidra® is usually used with a longer-acting insulin. When used as a
mealtime insulin, Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal.
Apidra® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Apidra®, please visit www.Apidra.com or call 800-633-1610.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the
hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is
estimated that approximately 285 million adults worldwide are living with the disease and this number is
expected to rise to a staggering 438 million within 20 yearsiii,iv. It is estimated that nearly 24 million Americans
have diabetes, including an estimated 5.7 million who remain undiagnosedv At the same time, according to
NHANES data from 2003-2004, approximately 40 percent of those diagnosed with diabetes did not achieve
the blood sugar control target of A1C <7 percent recommended by the ADAvi. The A1C test measures
average blood glucose levels over the past two-to-three-month period.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people
living with diabetes. The Company currently has insulin products, including Lantus®, Apidra® and Insuman®
(outside the U.S.)-- Lantus® and Apidra® are also available as injection pens (Lantus® SoloSTAR® and
Apidra® SoloSTAR®). Also available in some countries (outside the U.S.) is ClikSTAR®, a reusable insulin
injection pen for Lantus® or Apidra® for people with type 1 or type 2 diabetes. Following the formation of its
Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood
glucose monitoring solutions and the potential first regenerative treatment for diabetes. Investigational
compounds also in the pipeline include the once-daily injectable GLP-1 agonist lixisenatide as a
monotherapy and in combination with basal insulin as well as long-acting insulin analogs.
Clinical Update on TAMARIS Phase III Trial for NV1FGF Paris,
Sanofi-aventis announced that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen
pecaplasmid) did not meet its primary endpoint. The primary endpoint was to demonstrate the superiority of
NV1FGF vs. placebo in the prevention of major amputation or death from any cause over 12 months,
whichever came first, in critical limb ischemia patients who were not eligible for revascularization.
“We are disappointed that NV1FGF failed to achieve significance in the TAMARIS trial, and for patients who
are suffering from the dramatic consequences of this disease and are hoping for new treatments” said Marc
Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis. “We are evaluating all
options on the NV1FGF development and remain committed to innovation in diseases where there are major
healthcare needs and no therapeutic alternative”.
The full results of this trial will be presented at the American Heart Association Congress, on November 16,
2010 and are embargoed until this date.
TAMARIS is a randomized, double blind, placebo controlled study designed to evaluate the safety and efficacy
of NV1FGF in patients with critical limb ischemia and skin lesions who are not eligible for revascularization.
The study was conducted in more than 170 sites in 30 countries on five continents and enrolled a total of 525
patients being administered either NV1FGF or placebo intramuscularly every 2 weeks over a 6 week period.
Riferminogen pecaplasmid (NV1FGF) is a non viral plasmid-based gene local delivery system for human
fibroblast growth factor (FGF-1). FGF-1 promotes angiogenesis and induces the formation of new blood
vessels that could improve blood flow of the limbs of CLI patients.
pecaplasmid) did not meet its primary endpoint. The primary endpoint was to demonstrate the superiority of
NV1FGF vs. placebo in the prevention of major amputation or death from any cause over 12 months,
whichever came first, in critical limb ischemia patients who were not eligible for revascularization.
“We are disappointed that NV1FGF failed to achieve significance in the TAMARIS trial, and for patients who
are suffering from the dramatic consequences of this disease and are hoping for new treatments” said Marc
Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis. “We are evaluating all
options on the NV1FGF development and remain committed to innovation in diseases where there are major
healthcare needs and no therapeutic alternative”.
The full results of this trial will be presented at the American Heart Association Congress, on November 16,
2010 and are embargoed until this date.
TAMARIS is a randomized, double blind, placebo controlled study designed to evaluate the safety and efficacy
of NV1FGF in patients with critical limb ischemia and skin lesions who are not eligible for revascularization.
The study was conducted in more than 170 sites in 30 countries on five continents and enrolled a total of 525
patients being administered either NV1FGF or placebo intramuscularly every 2 weeks over a 6 week period.
Riferminogen pecaplasmid (NV1FGF) is a non viral plasmid-based gene local delivery system for human
fibroblast growth factor (FGF-1). FGF-1 promotes angiogenesis and induces the formation of new blood
vessels that could improve blood flow of the limbs of CLI patients.
GSK regulatory update on Avandia following EMA and FDA reviews
GlaxoSmithKline (GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.
In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA has stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.
In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl®) will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) programme with additional measures to ensure the safe use of the medicine.
Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding rosiglitazone-containing medicines. GSK will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.
Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent re-adjudication of the endpoints reported in the large, prospective, randomised, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency. TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe. GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).
In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA has stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.
In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl®) will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) programme with additional measures to ensure the safe use of the medicine.
Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding rosiglitazone-containing medicines. GSK will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.
Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent re-adjudication of the endpoints reported in the large, prospective, randomised, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency. TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe. GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).
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