BRIEF—Eisai files sNDA for Fycompa in Japan

Japanese pharma major Eisai has filed a supplementary new drug application (sNDA) in Japan for its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) seeking approval for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged four years and older, as well as a new fine granule formulation.

The submission covering monotherapy for partial-onset seizures was based on the results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea.

In FREEDOM, the percentage of untreated patients from 12 to 74 years of age with partial onset seizures who achieved seizure freedom with Fycompa monotherapy exceeded the criteria for efficacy, and the primary endpoint was met.

The most common adverse events (incidence of 10% or higher) observed in this study were dizziness, somnolence, nasopharyngitis and headache, which is consistent with the safety profile of Fycompa to date.

Available in tablet form to be taken orally once daily, Fycompa is approved in Japan as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs.