FDA green-lights Fycompa for treatment of partial-onset seizures
WOODCLIFF LAKE, N.J. — The U.S. Food and Drug Administration this week approved Eisai’s Fycompa (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
Fycompa is also approved for adjunctive use for partial-onset seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. It is the first antiepileptic drug to apply FDA's regulatory pathway of extrapolation for monotherapy use. The FDA had proposed using this pathway to get monotherapy options to patients sooner in a general advice letter dated Sept. 13, 2016.
"This approval is good news for the epilepsy community because it means that more physicians and patients will have access to a single agent option for partial-onset seizures," said Jacqueline A. French, MD, professor of neurology in the epilepsy division at NYU Langone Medical Center, chief scientific officer for the Epilepsy Foundation and director of the Epilepsy Study Consortium, a nonprofit organization devoted to speeding new therapies through the development process and into the clinic. "To date, conducting clinical trials with single agents in epilepsy has been problematic. Now, with this change in the regulatory pathway, we have a safe and efficient process for quicker access to single agent therapies for partial-onset seizures."
Fycompa was initially approved for adjunctive use in partial-onset seizures in 2012 and has been approved in 55 countries worldwide. To date, more than 100,000 patients have been treated with Fycompa. An oral suspension formulation was also approved in 2016. In the three initial adjunctive pivotal clinical trials in patients with partial-onset seizures, results showed improvement in seizure control in patients taking Fycompa compared with those taking placebo.