Orexigen Therapeutics (OREX) surged more than 110% to a two-year high Wednesday after announcing federal support for its weight loss drug Contrave, moving the drug maker one step closer to marketing approval.
An advisory committee to the US Food and Drug Administration focused on endocrinologic and metabolic drugs voted 13 to 7 that Contrave’s potential benefits outweigh potential risks when used long-term in a population of overweight and obese individuals. A positive vote meant the member supported its approval by the FDA.
The advisory committee’s decision offers a non-binding recommendation to be considered by the FDA in finalizing the review of Contrave New Drug Application, scheduled for Jan. 31.
"We are encouraged by the panel's view of the risk-benefit profile of Contrave," said Orexigen CEO Michael Narachi.
As part of a post-approval requirement, the drug, developed in partnership with Orexigen and Japan’s Takeda Pharmaceutical, has also been approved for a dedicated study to evaluate cardiovascular risks.