FDA Denial of Lorcaserin a setback for obesity treatment

October 23rd, 2010 by MorganDowney Leave a reply »


October 23, 2010 Washington , D.C.

Today the Food and Drug Administration rejected the application of Arena Pharmaceuticals Inc for approval of their drug, lorcaserin, for the treatment of obesity.

According to Morgan Downey, Editor and Publisher of the Downey Obesity Report (www.downeyobesityreport.com), “This action of the FDA is consistent with the pattern that no drug for obesity can be approved. They are searching for an unrealistic ‘magic bullet.’ The FDA has painted itself into a corner. They believe that a very effective drug will be taken by so many people that unforeseen adverse events will occur. They also believe that a drug which achieves moderate weight loss for patients is not worth any risk. This is an intolerable knot. This action is not about the effects of obesity and the benefits of weight loss. It is about the FDA fear of some future embarrassment.”

“In 2005, when the FDA turned down rimonabant, big pharmaceutical companies withdrew from obesity research and development. Since then, the only companies pursuing new drugs are small pharmaceutical companies. After this record of rejection, it will likely be 20 years before anyone tries to develop a drug to treat obesity,” said Downey.

Mr. Downey is the former executive director of  both the American Obesity Association and The Obesity Society. He is an advocate for obesity prevention and treatment. He works with many research and clinical organizations, including Arena Pharmaceuticals, addressing the obesity epidemic. His full biography is available at http://www.downeyobesityreport.com/morgan-downey-bio/

Information on the FDA letter is at FDA Issues Complete Response Letter for Lorcaserin New Drug Application (NASDAQ:ARNA)