FycompaTreatment for Epilepsy, Seizures
Update: Fycompa (perampanel) Now FDA Approved - October 22, 2012
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
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Jan 25, 2011 - Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies. Perampanel is a first-in-class, highly 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.
The clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305, and 304, in which a total of 1,490 patients participated. The key goal of Study 306 was to identify the minimal effective dose and included 4 treatment arms (placebo, 2mg, 4mg, and 8mg). Studies 304 and 305 included 3 arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range. The studies were similar in design: global, randomized, double-blind, placebo-controlled, dose-escalation, parallel-group studies. 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. Each of the studies showed consistent results in the efficacy and tolerability of perampanel given as an adjunctive therapy in patients with refractory partial seizures. Based upon these study results, Eisai intends to submit regulatory applications simultaneously in the U.S. and EU during the first quarter of our Fiscal Year 2011.
The development of perampanel is an example of Eisai's human health care corporate mission. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, 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.
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: Media Inquiries
Judee Shuler, 201-746-2241
David Melin, 908-255-6378
Posted: January 2011
- FDA Approves Fycompa to Treat Seizures - October 22, 2012
- FDA Accepts Resubmission of Perampanel New Drug Application - March 5, 2012
- Eisai Resubmits Perampanel (E2007) NDA to FDA - December 26, 2011
- U.S. FDA Provides Response to Perampanel New Drug Application - July 29, 2011