U.S. health regulators rejected Orexigen Therapeutics Inc.'s weight-loss drug and requested a clinical trial to resolve heart safety concerns, dealing a huge blow to what stood to be the first new diet pill in a decade.
Its shares tanked 73 percent to $2.44 on the news on Tuesday. The U.S. regulatory response raised new doubts about the drug industry's ability to develop prescription drugs to address obesity, a field littered with disappointments.
Hopes had run high for Orexigen's Contrave, one of three obesity drugs under U.S. review, after a Food and Drug Administration advisory panel in December voted 13-7 to recommend Contrave's approval.
But, according to the company, the FDA noted concern about the cardiovascular safety profile when used long-term in a population of overweight and obese subjects.
Contrave combines naltrexone, a medicine used to fight alcohol and drug addiction, with the antidepressant bupropion, in an attempt to boost metabolism while curbing appetite and cravings. Japan's Takeda Pharmaceutical Co. Ltd. holds North American marketing rights to Contrave.
The FDA told Orexigen it must conduct a study "of sufficient size and duration" to address the cardiovascular risks, the company said.
"We are surprised and extremely disappointed with the agency's request in light of the extensive discussion and resulting vote on this topic at the December 7 advisory committee meeting," Orexigen Chief Executive Officer Michael Narachi said in a statement.
Many industry analysts had predicted a delay to give the FDA more time to handle post-approval requirements, but thought that the drug was on track for approval in the coming months.
In company studies, at least 35 percent of patients lost 5 percent or more of their body weight.
The research also showed a slight rise in blood pressure and pulse rates with Contrave versus a placebo. The FDA panel of outside experts urged a long-term study of Contrave's heart risks after approval.
The fate of Contrave is key to California-based Orexigen, a company that focuses solely on obesity drugs and has no products on the market.
Drugmakers trying to fight fat with a pill have been thwarted for decades by serious side effects, and few options remain for sale in the United States.
The FDA rejected two other candidates, from Vivus Inc. and Arena Pharmaceuticals Inc. in October. Those companies are trying to meet FDA demands for more data on potential side effects.
Shares of Vivus were down 12 percent and shares of Arena dropped 5 percent after the Orexigen news.
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