Arena submits response to FDA's complete response letter for experimental weight-loss drug
Tuesday, January 03 2012 | Comments
and Arena Pharmaceuticals Inc.
reported that Arena recently responded to the complete response letter it received from the Food and Drug Administration
regarding the New Drug Application (NDA) for lorcaserin hydrochloride, an investigational weight-loss drug.
The reply to the FDA's complete response letter included data and analyses that were not incorporated in the original NDA for lorcaserin, such as findings from Arena's Phase III BLOOM-DM trial, which evaluated lorcaserin as weight-loss therapy in patients with type 2 diabetes. Newly submitted information also included data and analyses from activities intended to address tumors observed in a two-year rat carcinogenicity study of the drug, cell culture experiments intended to further refine serotonin subtype 2 receptor activity and rat studies designed to further assess abuse potential.
Arena and Eisai expect the FDA to confirm acceptance of the response later this month and assign a new Prescription Drug User Fee Act date for the lorcaserin NDA.
In October 2010, the FDA denied approval of lorcaserin, noting in the complete response letter that the drug had only marginal weight-loss efficacy in overweight and obese individuals without type 2 diabetes. The FDA also brought up nonclinical issues related to concerns about certain tumor-related findings in studies of laboratory rats that had been treated with lorcaserin.
At that time, the FDA requested additional information from Arena to allay the agency's concerns about the clinical relevance of these tumor-related findings in rats, adding that it could require the company to conduct additional trials to obtain "a more robust assessment" of the drug's benefit-risk profile if Arena could not provide sufficient evidence in some other way.
A few months later, the FDA asked Arena to conduct more research before lorcaserin would be considered for approval.
Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweight and have at least one weight-related comorbid condition.
In July 2010, Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, granted Eisai exclusive rights to market and distribute lorcaserin in the United States if the drug is approved.