New anti-obesity drug Lorcaserin receives backing by FDA experts
15th May 2012
A panel of independent experts has given its backing to new anti-obesity drug Lorcaserin, urging US Food and Drug Administration to approve the first new anti-obesity drug in more than a decade. The Food and Drug Administration is scheduled to decide on June 27 whether Lorcaserin should be approved for use in the U.S. The FDA does not have to follow the advice of its advisory panel although it often does. The FDA’s endocrinologic and metabolic drugs advisory panel voted 18 to 4, with 1 abstention, that Lorcaserin outweighed the potential risks when used long-term in a population of overweight and obese individuals. The drug was rejected in 2010 ago after safety concerns, however, the effects seen in that study did not appear in trials on overweight and obese humans, and the panel’s latest vote showed confidence that its benefits outweigh the risks. Lorcaserin works to control the appetite through receptors in the brain, and according to a study it helped nearly half of participants lose up to five percent of their body weight. If approved, it would most likely have to undergo follow up studies on how it affects the heart. The drug has been developed by US company Arena in conjunction with Eisai. Arena and Eisai are hoping that Lorcaserin will gain a new licence 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 co-morbid condition. Jack Lief, Arena’s president and chief executive officer, said in a statement, “The advisory committee’s positive vote supports our belief in Lorcaserin as a potential new treatment option for the medical management of overweight and obesity, we will continue to work with the FDA as the agency completes its review of the Lorcaserin new drug application.” FDA panel also urged the approval of another weight loss drug Qnexa back in February, with a decision expected to be made in mid-July as well.  Studies have shown that over weight people could lose up to 10 percent of their weight when taking Qnexa, along with regular exercise and following a healthy diet.