GlaxoSmithKline and Valeant get FDA approval for epilepsy drug Potiga

Following backing from a US Food and Drug Administration advisory panel last summer (The Pharma Letter August 12, 2010), the FDA issued a complete response letter but has now approved UK pharma giant GlaxoSmithKline (NYSE: GSK) and partner Valeant Pharmaceuticals International’s (NYSE/TSX: VRX) Potiga (ezogabine) tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

"We are so pleased to reach such an important milestone with the U.S. approval of Potiga by the FDA," stated Susan Hall, head of R&D at Valeant. "We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications," she added.

Analysts have forecast peak annual sales for Potiga ranging from $200 million to $800 million. Canada-based Valeant will receive up to 50% of US sales revenues under a development deal with GSK signed in 2008, which generated an upfront $125 million for Valeant and a further $545 million in milestone payments.