FDA advisory committee recommends approval for ezogabine

RESEARCH TRIANGLE PARK, N.C. A Food and Drug Administration advisory committee has given a nod of approval to an epilepsy drug made by GlaxoSmithKline and Valeant Pharmaceuticals International, the two drug makers said Wednesday.

The FDA’s Peripheral and Central Nervous System Drugs Advisory committee voted unanimously that the drug ezogabine was an effective treatment for adults with partial-onset seizures, and also voted that monitoring for infections and kidney stones for patients using the drug should not be instituted. The committee’s vote does not guarantee that the FDA will approve the drug, but the agency will take it into account when making its final decision.

“We are encouraged by the advisory committee’s assessment of the efficacy and safety of ezogabine and await a decision by the FDA,” said Atul Pande, SVP of the Neurosciences Medicines Development Center in GSK's North American pharmaceuticals division. “For appropriate patients, we believe ezogabine could offer an important adjunctive treatment option for partial-onset seizures that are not well-controlled.”