Wednesday, September 12, 2012

Eisai Launches FYCOMPA (perampanel) for treatment of Epilepsy in Europe

Eisai Co., Ltd. will launch the AMPA receptor antagonist Fycompa® (perampanel), a first-in-class antiepileptic agent discovered and developed in-house, in Europe ahead of other regions in the world for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalized seizures, in patients aged 12 years and older. Following the launch of the agent in the United Kingdom today, Fycompa will also be launched successively in European Union member states such as Germany, Austria and Denmark. Fycompa is a highly selective, non-competitive AMPA-type glutamate receptor antagonist.

In three global pivotal Phase III randomized, double-blind, placebo-controlled, dose-escalation studies which examined 1,480 epilepsy patients with partial-onset seizures, Fycompa consistently demonstrated excellent efficacy across all studies. The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls and ataxia. Fycompa was first approved by the European Commission (EC) in July of this year as the first and only antiepileptic drug (AED) to target AMPA receptors..

A New Drug Application for Fycompa was submitted in the United States in December 2012, while a
Phase III clinical study is currently underway in Japan for the same indication. Eisai is also conducting a
global Phase III study to evaluate the agent as a potential treatment for generalized epilepsy.

Eisai defines epilepsy as a therapeutic area of focus, with its currently marketed European epilepsy portfolio comprising Zonegran® (under license from the originator Dainippon Sumitomo Pharma Co., Ltd.) and Zebinix® (under license from the originator BIAL-Portela & Ca S.A.) for the treatment of adult epilepsy patients with partial-onset seizures, and Inovelon® (under license from the originator Novartis AG) for the
treatment of seizures associated with Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy. By enhancing its drug development capabilities in the field of epilepsy and providing multiple treatment options as part of an extensive epilepsy product portfolio, Eisai seeks to make further contributions to address