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Eisai to file MAA for Perampanel in US, EU

Eisai expects to file marketing authorization applications (MAA) in the US and the European Union for the investigational compound Perampanel (E2007) based on the results of three Phase III pivotal studies.

Perampanel is a selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial onset seizures in patients with epilepsy.

Accoding to Eisai, three global Phase III studies: Studies 306, 305, and 304 showed consistent results in the efficacy and tolerability of perampanel given as an adjunctive therapy in patients with refractory partial seizures.

The primary and secondary endpoints were the same in all the studies: standard median percent seizure reduction, 50% responder rate, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.