Posted by Michael Wonder on 27 Jul 2017
FDA approves Eisai's Fycompa (perampanel) for use as monotherapy for the treatment of partial-onset seizures
26 July 2017 - First anti-epileptic drug to apply FDA's regulatory pathway of extrapolation for monotherapy use; FDA proposed using this pathway to get monotherapy options to patients sooner.
Eisai Inc. announced today that the U.S. FDA has approved the company's supplemental new drug application for Fycompa (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalised 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 generalised tonic-clonic seizures in patients with epilepsy 12 years of age and older.
