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.

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