Fycompa now approved as monotherapy for partial-onset seizures in USA

The US Food and Drug Administration has approved Japanese pharma major Eisai’s (TYO: 4568) supplemental New Drug Application (sNDA) for Fycompa (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

In addition to the new monotherapy use in POS, Fycompa is approved for adjunctive use for POS and primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy 12 years of age and older.

Fycompa is the first AED approved by the FDA following the pathway outlined in the agency's September 13, 2016 General Advice Letter to AED NDA holders stating "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 for the treatment of POS." Fycompa's approval for monotherapy use has been extrapolated based on comparable exposures to those obtained with adjunctive use in clinical trials for the treatment of partial-onset seizures.