Eisai Epilepsy Drug Snags Expanded Indication

June 26, 2015

Eisai has received FDA approval of an expanded indication for its antiepileptic drug Fycompa as an adjunctive treatment for primary generalized tonic-clonic seizures in epilepsy patients 12 and older.

The FDA based its decision on a Phase 3 study of 164 patients, which showed a significant reduction in PGTC seizure frequency among patients receiving Fycompa (perampanel hydrate) — 76.5 percent versus 38.4 percent of patient receiving a placebo. Additionally, 30.9 percent of Fycompa patients were free of PGTC seizures during a 13-week maintenance period, compared with 12.3 percent of patients in the control arm.

Fycompa was approved as an adjunctive treatment for partial-onset seizures in October 2012, but did not launch until January 2014. Eisai subsequently sued the FDA, claiming the government arbitrarily shortened its five-year exclusivity from generics competition.

In a complaint filed in August 2014, Eisai argues that Fycompa’s release was delayed because it needed to be scheduled by the Drug Enforcement Administration under the Controlled Substances Act, due to the potential for abuse.

Eisai says the exclusivity clock started while the company was waiting for the drugs to be scheduled, when it would have been illegal to market them, and that that constitutes a violation of the guaranteed exclusivity. The firm filed a request June 16 in U.S. District Court for the District of Columbia for a status conference to resolve the matter. — John Bechtel