FDA Accepts Resubmission of Perampanel New Drug Application

Woodcliff Lake, NJ, March 5, 2012 - Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's resubmission of the New Drug Application (NDA) for perampanel(E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of October 22, 2012.

Acceptance of the NDA indicates that the FDA has found the company's resubmission to be sufficiently complete to review. The original NDA was submitted to the FDA on May 25, 2011 and the FDA issued a Refuse to File letter on July 29, 2011. The NDA was resubmitted on December 22, 2011.

About Perampanel

Perampanel is an orally administered, highly selective non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist, discovered and being developed by Eisai. The AMPA receptor is widely present in almost all excitatory neurons.

About Eisai Inc.

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.
 

Type Press Release

Date Released March 05, 2012

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