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US panel to review Ovation's Sabril for epilepsy

This article was originally published in Scrip

Executive Summary

The US FDA's peripheral and central nervous system drugs advisory panel will meet for two days next month to evaluate Ovation's epilepsy drug Sabril (vigabatrin). On August 6th the committee will discuss the NDA for adjunctive therapy in treating refractory partial seizures in adults. Vigabatrin's use for infantile spasms will be considered on August 7th. Both indications are undergoing a priority review; the user fee deadline was June 30th, but the FDA has informed the company that it expects to take an additional two months. Ovation said it anticipates receiving an action letter by the end of August and a final decision in the fourth quarter. The company acquired North American rights for Sabril, an irreversible GABA-transaminase inhibitor, from Aventis (nowSanofi-Aventis) in 2004. Vigabatrin is marketed for epilepsy in more than 50 countries but has been associated with visual field defects. The drug is also being tested in the US as a treatment for methamphetamine and cocaine dependence.

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