Posted by Michael Wonder on 31 May 2018
U.S. FDA designates for priority review Eisai's supplemental new drug application for anti-epiletic drug Fycompa as treatment for paediatric patients with epilepsy
31 May 2018 - Eisai has announced the U.S. FDA has accepted for review the supplemental new drug application for Eisai’s anti-epileptic drug Fycompa (perampanel).
This application seeks approval for an indication expansion to cover paediatric patients with partial onset seizures and primary generalised tonic-clonic seizures. Furthermore, Eisai has included a study in this application requested by the FDA in a paediatric written request, and therefore FDA has designated this application for priority review, which means the review period will be six months.
The FDA has assigned a Prescription Drug User Fee Act action date of 28 September 2018.
