FycompaTreatment for Epilepsy, Seizures
Update: Fycompa (perampanel) Now FDA Approved - October 22, 2012
FDA Accepts Resubmission of Perampanel New Drug Application
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Mar 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.
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.
Contact: Eisai Inc.
Marcia J. Diljak, 201-746-2236
Alex Scott, 201-746-2177
Posted: March 2012
- FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-onset Seizures - July 27, 2017
- Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension - May 2, 2016
- FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures - June 22, 2015
- FDA Approves Fycompa to Treat Seizures - October 22, 2012
- Eisai Resubmits Perampanel (E2007) NDA to FDA - December 26, 2011
- U.S. FDA Provides Response to Perampanel New Drug Application - July 29, 2011
- Eisai to Submit Marketing Authorization Applications in the U.S. and EU for Perampanel as Adjunctive Therapy for Partial Onset Seizures in Patients with Epilepsy - January 25, 2011