GlaxoSmithKline (GSK) and Valeant Pharmaceuticals (Valeant) have provided updates on the New Drug Application for retigabine.
GSK and Valeant had filed a New Drug Application with the FDA and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMEA) on 30 October, for retigabine, used as adjunctive therapy to treat adult epilepsy patients with partial-onset seizures.
Both the companies had entered into an exclusive worldwide collaboration agreement for the investigational drug retigabine, a first in class neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown robust efficacy and safety as demonstrated in two large, completed Phase III trials conducted in patients with refractory epilepsy receiving treatment with up to three antiepileptic drugs (AEDs).
The companies have reported that retigabine is not approved or licensed anywhere in the world.