Locaserin: Government Advisors Recommend FDA Approval of New Obesity Drug
May 24, 2012 § Leave a Comment
The Endocrinologic and Metabolic Drugs Advisory Committee arm of the U.S. Food and Drug Administration (FDA) voted to recommend the approval of lorcaserin, a new obesity drug from Arena Pharmaceuticals, Inc. and Eisai, Inc.
The recommended approval comes when the same panel had rejected its recommendation in September 2010 over health concerns. However, the current recommendation received a voting of four against, 18 in favor, and one who abstained that the benefits of locaserin outweigh the risks.
In people who are clinically obese or overweight, Locaserin is indicated for weight loss and weight maintenance. It works by acting as a selective serotonin 2C receptor, noted in the press release.
About one-third of American adults are battling obesity, which raises the risk of heart disease, diabetes, and other illnesses. “It is not really the answer to the obesity problem, but it may be a steppingstone to help us out,” said Dr. Eric I. Felner, a pediatric endocrinologist at Emory University who was on the 18 who voted in favor of approval.
Although the FDA’s advisory committees provide recommendations to the FDA, its the FDA that has the authority in making the final decision. The FDA has until June 27, 2012 to decide whether to give approval for sales of the drug. While the FDA is not bound to take its committee’s recommendation advice of its advisory panels, in many cases it does.
If the FDA approves the sale of locaserin, it will be the first new weight-loss prescription medication in the United States in over 10 years.’
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
