FDA reviews coming out on 3 new obesity drugs
WASHINGTON — 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, but have worrying side ef fects. Qnexa has an anticonvulsant and an amphetamine, and Contrave mixes an antidepressant with an anticonvulsant. Lorcaserin is a new medication, and 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 fenphen, 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 today and will hold a public meeting Thursday to review the data. Orexigen Therapeutics Inc.’s Contrave is set for review in October, and Arena Pharmaceuticals Inc.’s lorcaserin is set for December.
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.