(SAN DIEGO) -- The U.S. Food and Drug Administration rejected a New Drug Application from Arena Pharmaceuticals, Inc. and Eisai Inc. for lorcaserin.
In a letter to the companies, the FDA cited various safety concerns, both clinical and non-clinical, to support their decision not to approve the new drug intended for obese patients living with weight-related comorbid conditions.
The FDA also recommended that lorcaserin be placed in Schedule IV of the Controlled Substance Act after careful review of data submitted in the new drug application. The companies applying for the approval of lorcaserin were also offered the opportunity to "complete pre-clinical studies that may lead to a different recommendation."
"Eisai is committed to collaborating with Arena to address the FDA's requests. Obesity is an epidemic in America, and our goal is to bring locaserin to physicians and patients who need additional weight-loss options," said Lonnel Coats, President and CEO of Eisai Inc.
Arena plans to request a meeting with FDA officials to "clarify its requests." FDA guidelines state that if a meeting is granted, it must take place within 30 days of the request.
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