Posted by Michael Wonder on 03 Apr 2018
Eisai submits supplemental new drug application to FDA for Fycompa (perampanel) paediatric indications
31 March 2018 - First step to making Fycompa available for children, underscoring Eisai's commitment to epilepsy care for patients of all ages.
Eisai announced today that it has submitted a supplemental new drug application for priority review to the U.S. FDA for its antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures with or without secondarily generalized seizures in paediatric patients (ages 2 to less than 12 years).
The submission also proposes a paediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures in children (ages 2 to less than 12 years) with epilepsy. The sNDA is for both the Fycompa tablet and oral suspension formulations.
