Posted by Michael Wonder on 01 Oct 2018
Fycompa newly approved by U.S. FDA as treatment for partial-onset seizures in paediatric patients with epilepsy
1 October 2018 - Eisai announced today that its U.S. subsidiary has received approval from the U.S. FDA for an indication expansion for Eisai's anti-epileptic drug Fycompa (perampanel) to cover partial-onset seizures in paediatric patients with epilepsy 4 years of age and older.
Fycompa was designated for priority review by the FDA, and was approved approximately six months after submission.
Through this latest approval, Fycompa is indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalised seizures) in patients with epilepsy 4 years of age and older. This approval was based on the interim results of a Phase III clinical study (Study 311) as well as the results from a Phase II clinical study (Study 232) in paediatric patients with epilepsy. Both studies confirmed the safety and efficacy of Fycompa were similar between adult and paediatric patients.
