SAN DIEGO (AP) – Arena Pharmaceuticals Inc. said it plans to again ask the Food and Drug Administration to approve its experimental weight-loss drug lorcaserin by the end of 2011, following the agency’s recent rejection over safety concerns.
Lorcaserin, being developed with Eisai Inc., is Arena’s most advanced clinical product and a major potential revenue producer. The company made the announcement after it completed a review meeting with the agency. It said it will continue to “refine elements” of its plan to again ask for approval.
In October, the agency rejected lorcaserin and potential competitor Vivus Inc.’s Qnexa because of safety concerns. Both the drugs had been given negative recommendations by an FDA panel of experts prior to the agency’s rejection. Specifically, the agency was concerned that about tumors seen in rats in early-stage lorcaserin testing, one of the factors that Arena Pharmaceuticals said the FDA had cited in a letter responding to the company’s application. In addition, the FDA has said the drug was only marginally effective in overweight and obese individuals without type 2 diabetes.
Meanwhile, competitor Vivus plans on meeting with the agency in January and has already asked European regulators to approve Qnexa. The FDA rejected the drug initially because of concerns over potential heart problems and birth defects.
So far, Orexigen Therapeutics Inc.’s Contrave is the only weight-loss drug to gain a positive recommendation from a panel of FDA experts. The FDA is scheduled to make a decision on the drug by Jan. 31.
Date: December 22, 2010
Source: Associated Press
Filed Under: Drug Discovery