FDA panel of advisers backs GlaxoSmithKline seizure drug, despite side effects

FDA panel favors Glaxo epilepsy drug

WASHINGTON — Federal health advisers have ruled that GlaxoSmithKline’s epilepsy drug Potiga effectively controls seizures.

An agency spokeswoman said Wednesday the Food and Drug Administration’s panel of neurologists voted unanimously that company studies showed the effectiveness of the drug. The panelists noted side effects, including the inability to urinate, but said they could be controlled by carefully monitoring patients.

The FDA is not required to follow the advice of its panelists, though it usually does.

British drugmaker GlaxoSmithKline PLC has asked the FDA to approve the pill for epilepsy patients who continue experiencing seizures while taking other medications. The company said in a statement it is “encouraged” by the panel ruling and awaits a final decision by the FDA.

Global sales of drugs to treat epilepsy reached nearly $13 billion last year, according to health care data firm IMS Health. Epilepsy drugs already on the market include Johnson & Johnson’s Topamax and Pfizer Inc.’s Neurontin.

If approved, Potiga would be used as a second-line treatment for patients whose seizures are not well-controlled using existing drugs. Glaxo studied the drug in three trials which showed that patients taking Potiga saw a reduction in seizures compared with those taking a dummy pill.

Potiga was co-developed with Valeant Pharmaceuticals International, which is based in Aliso Viejo, Calif.