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Arena Submits Response to FDA Complete Response Letter for Lorcaserin
By Benzinga Staff
January 05, 2012 5:38 AM
January 05, 2012 5:38 AM
Tokyo, Jan 5, 2012 - (JCN Newswire) - Eisai Co. Ltd announced today that Arena Pharmaceuticals Inc. has submitted its response to the Complete Response Letter (CRL) issued by the U.S. Food and Drug Administration (FDA) following review of the lorcaserin (generic name) New Drug Application (NDA).
Lorcaserin, which Arena discovered and has developed, is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, BMI of 30 or higher) or patients who are overweight (BMI of 27 or higher) and have at least one weight-related co-morbid condition. Lorcaserin is the subject of an exclusive licensing agreement concluded between Eisai's U.S. Subsidiary Eisai Inc. and Arena Pharmaceuticals GmbH, the wholly-owned Swiss subsidiary of Arena concerning its marketing and supply in the United States.
The response submitted by Arena is intended to address the FDA's requests as outlined in the CRL, which includes data from the Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes. The response also includes data and analyses from activities conducted to investigate tumors observed in a lorcaserin rat carcinogenicity study.
It is anticipated that the FDA will confirm its acceptance and assign a new Prescription Drug User Fee Act (PDUFA) date.
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 www.eisai.co.jp/index-e.html
Source: Eisai
Contact:
Copyright 2011 JCN Newswire. All rights reserved. www.japancorp.net
Lorcaserin, which Arena discovered and has developed, is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, BMI of 30 or higher) or patients who are overweight (BMI of 27 or higher) and have at least one weight-related co-morbid condition. Lorcaserin is the subject of an exclusive licensing agreement concluded between Eisai's U.S. Subsidiary Eisai Inc. and Arena Pharmaceuticals GmbH, the wholly-owned Swiss subsidiary of Arena concerning its marketing and supply in the United States.
The response submitted by Arena is intended to address the FDA's requests as outlined in the CRL, which includes data from the Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes. The response also includes data and analyses from activities conducted to investigate tumors observed in a lorcaserin rat carcinogenicity study.
It is anticipated that the FDA will confirm its acceptance and assign a new Prescription Drug User Fee Act (PDUFA) date.
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 www.eisai.co.jp/index-e.html
Source: Eisai
Contact:
Public Relations Department Eisai Co. Ltd T: +81-(0)3-3817-5120
Copyright 2011 JCN Newswire. All rights reserved. www.japancorp.net
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