Diet Pill Lorcaserin Closer to FDA Approval
Posted: May 13, 2012
The planned diet pill Lorcaserin, which was turned down for Food and Drug Administration approval last October, got a recommendation from the advisory committee, a major greakthrough in gaining FDA approval. If the FDA follows the advice of the panel of independent experts which it usually does but is not mandatory Lorcaserin would become the first new prescription weight-loss drug to go on the U.S. market since Orlistat (also known as the OTC Alli) was approved in 1999.
The 18-4 vote of the FDA’s advisory committee on endocrinological and metabolic drugs weighed evidence on the drug’s safety record, presented by Lorcaserin’s sponsor, Arena Pharmaceuticals, which developed Lorcaserin in partnership with Eisai Co. Panel members also weighed Lorcaserin’s success in promoting weight loss in obese patients next to concerns that the drug might damage heart valves, as well as about increased rates of breast and brain tumors in animals given higher than the planned dose. Those were the issues that led the FDA to send Arena Pharmaceuticals back to gather more data.
Lorcaserin is a anorectic diet pill (like phentermine) with a structure similar to dexfenfluramine, an anorectic drug that was withdrawn because of cardiovascular side-effects. If approved it will only be available through your doctor and only for obese patients, and though it had a recommendation from the advisory panel it could still be more than a year to see if it is approved.