Vivus Inc.’s weight-loss drug candidate Qnexa failed to win over U.S. health regulators, who declined to approve the diet pill, asking for evidence related to heart risk and other information.
The Food and Drug Administration told Vivus on Thursday that its new drug application for Qnexa could not approved in its present form.
The FDA, among other things, asked Vivus for evidence that a higher heart rate associated with the drug does not increase the risk of major heart problems.
Vivus said it was preparing a response to the FDA’s letter and expects to submit it to the FDA in about six weeks.
Vivus is among several drugmakers vying to market the first new prescription diet drug in more than a decade and the second to be rejected recently. Last week the FDA denied approval for Arena Pharmaceuticals Inc’s (ARNA.O) experimental pill.
Arena, which is partnering with Eisai Co., said FDA officials were concerned about a lack of meaningful weight loss and cancer findings in rats with an unknown impact on people.
Both companies’ struggles — along with the withdrawal of Abbott Laboratories Inc.’s Meridia earlier this month — highlight the challenge of developing a safe medication to meaningfully treat the two-thirds of Americans who are overweight or obese.
Despite soaring obesity rates, manufacturers have failed to find success, leaving the current market untapped at roughly just $381.5 million in 2009, according to IMS Health.
FDA’s advisers earlier this year also recommended against approving Qnexa. They cited concerns about depression, memory loss, possible birth defects, among other risks amid potential wide use among patients who are not necessarily obese but who want to lose a few pounds.
Since then, however, the company has said new 2-year data showed better weight-loss results and improved safety.
Thursday’s rejection leaves Orexigen as the last remaining drugmaker with a diet drug under FDA review. It presents its case to the agency’s outside advisers Dec. 7. It is partnering with Takeda Pharmaceutical Company Limited (4502.T) to market the drug, called Contrave, if ultimately approved.
