The drug has been approved in 55 countries and used to treat 100,000 patients.
The US Food and Drug Administration (FDA) has approved Eisai Inc.’s supplemental New Drug Application (sNDA) for perampanel (FYCOMPA), a monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years or older.
FYCOMPA is the first antiepileptic drug (AED) approved by the FDA following a pathway outlined in the agency’s 2016 General Advice Letter to AED NDA holders, which stated, “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy or the treatment of POS.”
As such, the drug’s approval for monotherapy was extrapolated based on exposures comparable to those obtained with adjunctive use in trials for the treatment of POS.
FYCOMPA is also approved for adjunctive use for POS and primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy 12 years of age and older. The drug was initially approved for adjunctive use in POS in 2012, and has since been approved in 55 countries and used to treat more than 100,000 patients.
“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 Consortioum. “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 is supplied in 2, 4, 6, 8, 10, and 12 mg film-coated tablets and in an oral suspension formulation. It is designated by the US Drug Enforcement Administration as a federally-controlled substance (CIII).