FDA Panel Brings Orexigen's Obesity Drug a Step Closer to Market

Includes: OREX, TKPHF
by: The Burrill Report

By Michael Fitzhugh

Orexigen Therapeutics' (NASDAQ:OREX) experimental obesity drug Contrave cleared a crucial hurdle at the U.S. Food and Drug Administration, allowing the drug to advance a step closer to possibly landing the agency’s first approval for a new diet pill in a decade.

Members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met December 7 to scrutinize Contrave’s potential risks, voting 13-7 in favor of recommending it for approval. The victory set Orexigen’s shares on fire, boosting their value by more than 80 percent to $8.77 during the Nasdaq trading session that followed the vote.

Contrave’s potential approval has excited investors in large part because of the limited range of options available to the growing number of overweight and obese people in the United States. Dieting and exercise, the first lines of prescription for weight loss, often prove too difficult for patients to stick to over time. Orlistat, an approved weight loss drug that prevents some fats from being absorbed by the intestines, has turned out to be ill-tolerated by some patients. Meanwhile, the benefits of surgical options, such as gastric banding and bariatric surgery, can be off-set by greater expense and risk.

The latest crop of contenders for FDA approval has faced trouble too. Arena’s Lorqess, failed to win the panel’s support after being hobbled by concerns that it may have been carcinogenic in lab rats and succeeded by just “a slim margin” in meeting the FDA’s expectations for weight management. Concerns over extended use derailed Qnexa, a diet drug developed by Vivus that the panel declined to support in October.

Contrave largely slipped past such worries, with clinical tests adequately demonstrating its benefits outweighed its potential risks when used long-term by overweight and obese people the panel’s majority decided. Those benefits included clinically meaningful weight loss that was greater than that observed with either of the two drugs that, in combination, would be marketed as Contrave.

While the FDA is not required to follow the panel’s advice to approve a drug, it frequently does. If Contrave wins approval, Orexigen and Takeda (OTCPK:TKPHF) would be responsible for keeping close tabs on the drug’s impact on patients. They’ll could get a chance to do that soon enough. The FDA is due to decide whether to approve or reject the drug by January 31, 2011.