CHMP seeks more details on Belviq's risk-benefit
Arena Pharmaceuticals Inc. (NASDAQ:ARNA) fell $0.95 (10%) to $8.82 on Tuesday after disclosing in an SEC filing that EMA's CHMP requested that the company "further justify" the overall benefit-risk balance of Belviq lorcaserin in light of previously identified non-clinical and clinical issues. Arena said the request came in a list of outstanding questions on an MAA for the obesity drug. According to the company, the issues include tumors in rats, valvulopathy and undisclosed psychiatric events.
FDA had previously expressed concern about mammary masses in female rats, but the agency approved the serotonin (5-HT2C) receptor agonist last year for chronic weight management. The approval requires a postapproval cardiovascular outcomes trial to monitor concerns about valvular heart disease. Belviq's U.S. label notes that events of euphoria, hallucination and dissociation were seen at supratherapeutic doses of Belviq in short-term studies. Arena could not be reached for details. ...