Acceptance of the NDA indicates that the FDA has found the company's resubmission to be sufficiently complete to review. Eisai originally submitted the perampanel NDA to the FDA in May 2011, however, resubmitted it in December 2011 after reformatting and reanalyzing some datasets in the dossier as requested by the FDA in a Refuse to File letter issued in July 2011.
Perampanel is a novel chemical entity discovered and being developed by Eisai. If approved, the agent will be the first in a new class of highly selective, non-competitive AMPA-type glutamate receptor antagonists. Eisai defines epilepsy as a therapeutic area of focus, and seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, epilepsy patients and their families by offering them multiple treatment options.
About Eisai
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit http://www.eisai.co.jp/index-e.html
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Mar 6, 2012 Source: Eisai Eisai (TSE: 4523) (U.S: ESALY) From the Japan Corporate News Network http://www.japancorp.net Topic: Press release summary View more news from these Sectors: Biotech, Drugs & OTC
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U.S. FDA Accepts Resubmission of AMPA Receptor Antagonist Perampanel (E2007) New Drug Application