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Eisai to apply for approval of new epilepsy drug
Eisai is to apply for regulatory approval in the EU and US for a new drug for the adjunctive treatment of partial seizures in patients with epilepsy.
Marketing authorisation applications will be submitted to the European Medicines Agency (EMA) and US Food and Drug Administration for the investigational compound perampanel during the first quarter of this year.
These applications will be supported by data from three global phase III studies, all of which demonstrated that the drug is both efficacious and tolerable among patients in this specification.
Eisai has expressed confidence that perampanel has the potential to become the next leading product in the field of neurology behind its Alzheimer's disease treatment Aricept.
A company statement added: "Eisai seeks to make further contributions to addressing the diversified needs of and increasing the benefits provided to epilepsy patients and their families."
Earlier this week, the company was granted a recommendation from the EMA's Committee for Medicinal Products for Human Use for approval of its breast cancer drug Halaven.
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