Update: Halaven (eribulin mesylate) Now FDA Approved - November 15, 2010
Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Aug 30, 2010 - Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010.
The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing and controls (CMC) section of the NDA as a major amendment to the NDA. The new action date will give the agency additional time to review the information submitted for this complex synthetic process.
In addition to the U.S. FDA priority review, eribulin is currently under active regulatory review in Japan, the European Union (EU), Switzerland and Singapore.
Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai seeks to further address the diversified needs of patients and families affected by cancer, and their healthcare professionals.
Eribulin mesylate (E7389) is an investigational agent being evaluated as a potential treatment for locally advanced or metastatic breast cancer. A non-taxane, microtubule dynamics inhibitor, eribulin is a synthetic analog of halichondrin B, which is derived from a natural product isolated from the marine sponge Halichondria okadai. Eribulin is the state of the art in modern synthetic chemistry, which has 826 of molecular weight, 62 steps of total synthetic route and 19 chiral carbons.
About Advanced or Metastatic Breast Cancer
Advanced or metastatic breast cancer occurs when a malignant tumor in the breast spreads from its original site to other parts of the body. Approximately 50 percent of women worldwide initially diagnosed with breast cancer are expected to develop recurrent or metastatic disease within 15 years of their first diagnosis. Only one in five women with metastatic breast cancer survives longer than five years. In the U.S., an estimated 155,000 women are currently living with metastatic breast cancer, and that number is projected to increase to 162,000 by 2011.
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., 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 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.
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 health care system. Eisai employs approximately 11,000 employees worldwide.
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Contact: Eisai Inc.
Lynn Kenney, 201-746-2294 (office)
Dave Melin, 908-255-6378 (office)
Posted: August 2010
- FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma - January 28, 2016
- FDA Approves Halaven for Late-Stage Breast Cancer - November 15, 2010
- Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU - March 31, 2010
- Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application - February 1, 2008