UPDATE: FDA Panel Backs Proposed Glaxo, Valeant Epilepsy Drug

A Food and Drug Administration panel Wednesday backed a proposed epilepsy drug called Potiga developed by Valeant Pharmaceuticals International (VRX) and GlaxoSmithKline PLC (GSK, GSK.LN).

The panel unanimously said the companies provided data showing the product was effective as an add-on treatment in certain epilepsy patients. The panel also said it believed patients could be monitored for urinary side effects, which the FDA said is the main safety concern with the product.

Specifically, 11 members of the panel said urinary retention could by "mitigated by patient monitoring" while two people abstained from voting on that question.

Potiga, also known by its generic name ezogabine, is being reviewed Wednesday by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. The positive votes on its effectiveness and safety amount to a recommendation that the FDA approved the product. The FDA usually follows the advice of its panels of non-FDA medical experts but is not required to.

In a statement, Atul Pande, a GlaxoSmithKline senior vice president, said the company is "encouraged by the advisory committee's assessment of ezogabine" and awaits a decision by the FDA.

Potiga is designed to treat adults with partial onset seizures who aren't adequately treated with other medications. Potiga would be added to other medications.

Epilepsy is a brain disorder, often marked by seizures, in which clusters of nerve cells, or neurons, in the brain sometimes signal abnormally. The condition affects about 3 million people in the U.S.

Valeant is being acquired by Canadian pharmaceutical firm Biovail Corp. (BVF) in a deal that's expected to close by the end of the year.

In a briefing memo prepared for the meeting, the FDA said three clinical trials looking at different doses of Potiga showed it helped reduce the number of seizures in patients compared with those who weren't receiving the drug when given three times a day. The FDA said most cases of urinary retention seen in clinical studies were reversible. Other side effects seen with Potiga included dizziness and fatigue.

Officials representing Valeant told the panel that about one-third of epilepsy patients are not adequately treated with current medications and that many of those patients could benefit from the addition of Potiga. They said Potiga's side effects could be managed and noted that various side effects are seen with the other 17 antiepileptic drugs on the market.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

Biovail (NYSE:BVF)
Historical Stock Chart
From May 2024 to Jun 2024