FDA Panel Backs Orexigen's Diet Pill
Orexigen Therapeutics's (OREX) weight-loss drug Contrave could become the first diet pill to be approved in a decade -- and a potential blockbuster -- after a U.S. Food and Drug Administration panel of outside advisers backed the drug on Tuesday.
The panel voted 13-7 to recommend the approval of Contrave, saying the medicine's benefits in helping obese people lose weight outweigh its potential risks. In an earlier vote of 11-8, with one abstention, the panel said that a study on whether Contrave increases the risk of heart attacks and strokes should be done after, not before, approval.
The decision is sure to come as a relief to Orexigen. On Friday, the FDA released documents that raised concerns about Contrave's safety -- it said that while the drug indeed helped some people lose weight, some users saw a small increase in their heart rate and blood pressure -- and caused Orexigen shares to tumble some 10%.
Orexigen argued that the benefits of the drug, which include lowering the risk of obesity-related diseases such as diabetes, outweigh the modest risks. Trading on OREX shares was halted Tuesday while the panel met.
Contrave, developed in partnership with Takeda, is a combination of two already-approved drugs: the antidepressant bupropion, which also elevates blood pressure, and the anti-addiction drug naltrexone. By boosting users' metabolism while curbing their appetite and cravings, Contrave aims to fight both biological and behavioral causes of obesity.
Third Time's the Charm?
The drug is the third of a trio of weight-loss drugs to appear before the panel in recent months. FDA rejected both Arena's (ARNA) lorcaserin and Vivus's (VVUS) Qnexa after the companies failed to convince the panel that the drugs were effective or safe.
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"We are deeply concerned about the effect that the FDA's recent decisions will have for ongoing and future research into desperately needed new obesity treatments," Dr. Jennifer Lovejoy, president of The Obesity Society, said in a statement released ahead of the panel. "It is imperative that the FDA review any obesity treatment presented to them with the understanding that more than 93 million Americans are depending on them for help with this disease."
The panel's support of Contrave could be giving Arena and Vivus investors some hope that those companies' weight-loss drugs may ultimately be approved too. Vivus shares rallied more than 10% during market hours Tuesday, then gained more than another 10% in after-hours trading, while Arena shares -- which grew more than 2% by the market close Tuesday -- jumped 12% in extended trading.
Pills aren't the only treatment available to combat obesity, of course. A weight-loss device recently fared better with the panel than the Iorcaserin or Qnexa pills. The FDA on Friday expanded its approval for Allergan's (AGN) lap-band implant, paving the way for its use in less obese patients.
And with Americans getting fatter and obesity becoming a public health issue, the FDA will likely be considering many more obesity treatments in the future.
The FDA is scheduled to make a decision on Contrave on Jan. 31. While the regulatory authority usually follows the panel's advice, it doesn't have to.
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