FDA To Review First Of 3 New Weight Loss Drugs
WASHINGTON (AP) â¿¿ Dieters, doctors and investors get their first extensive look at the first of a trio of new weight loss drugs this week. The hope is that the new drugs can succeed where many others have failed: delivering significant weight loss without risky side effects.
With U.S. obesity rates nearing 35 percent of the adult population, expectations are high for the first new prescription drug therapies to emerge in more than a decade. Even a modestly effective drug has blockbuster potential.
None of the three medicines represents a breakthrough in research. Drugmakers have made little headway in understanding and treating the causes of overeating. Two of the drugs submitted for approval simply combine existing drugs â¿¿ an anticonvulsant and an amphetamine â¿¿ but have worrying side effects. The third, a new medication, is safer but less effective.The quest for a blockbuster weight loss drug has been plagued for decades by safety issues. The most notable was Wyeth's diet pill drug combination fen-phen, which was pulled off the market in 1997 due to links to heart valve damage and lung problems. The FDA is expected to post its review of Vivus Inc.'s pill Qnexa on Monday and will hold a public meeting Thursday to review the data. Arena Pharmaceuticals Inc.'s lorcaserin is set for an FDA panel review in September, while Orexigen Therapeutics Inc.'s Contrave will be the subject of a December panel. "There's no obvious clear winner," said Leerink Swann analyst Steve Yoo. "If you look at different aspects, each drug shines." To be considered effective, obesity drugs should reduce total body weight by at least 5 percent after one year, according to FDA guidance to companies. Qnexa showed the best weight loss results in clinical trials, with patients losing between 13 percent and 15 percent of their body weight. But the drug also had the highest rate of patient dropouts due to side effects, which include memory and concentration problems.
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