GlaxoSmithKline and Valeant got a solid endorsement for their new epilepsy drug Potiga (ezogabine) from the FDA's panel of experts, putting them on track to a likely approval. The experts unanimously agreed that the drug would benefit epilepsy patients whose meds couldn't stop seizures. And they agreed that careful monitoring would flag patients who experience an inability to urinate while taking the drug.
Two of the experts abstained on the main safety issue, which is typically reversible once spotted. And while the agency won't be bound by the expert backing, it's rare to see them go against this kind of tide. "For appropriate patients, we believe ezogabine could offer an important adjunctive treatment option for partial-onset seizures that are not well-controlled," said Atul Pande, a Glaxo senior vice president.
That leaves the two developers laying the groundwork to begin marketing a new therapy for the $13 billion U.S. epilepsy market, where they say about a third of all patients could benefit from the drug. The vote is also good news for Biovail, which has a deal to buy Valeant.
- read the Valeant release
- see the WSJ story