GlaxoSmithKline (NYSE: GSK) says its seizure drug developed with Valeant Pharmaceuticals Inc. has been granted marketing authorization by the European Union.

Trobalt is intended to treat partial onset seizures in adults with epilepsy. The EU approval comes after the Committee for Medicinal Products for Human Use recommended Trobalt be approved for patients who are already using another therapy. The committee makes recommendations to the European Medicines Agency.


“The European authorization of retigabine is very welcome as it will provide neurologists within Europe with a new therapeutic option for the management of appropriate patients with uncontrolled partial onset seizures,” said Dr. Tony Hoos, GSK’s senior vice president of European Medical Affairs for GSK.


Trobalt is also called retigabine, and in the U.S., it is called ezogabine. The U.S. Food and Drug Administration refused to approve the drug in December, saying it needed additional non-clinical information. The companies are working on a response.

GSK said the companies “are working to submit a response to the FDA as soon as possible in 2011.”

Read GSK’s announcement here.

GSK employs some 4,000 people at its U.S. headquarters in Research Triangle Park, N.C. 

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