The US Food and Drug Administration has rejected a marketing request by Vivus for its new obesity treatment called Qnexa, because it considers it a health risk, the California-based biotech firm said in a statement.
The FDA issued a letter "to communicate its decision that the NDA (New Drug Application for Qnexa) cannot be approved in its present form," the company said.
In its decision, the FDA followed the July recommendations of its expert panel on endocrinological and metabolic drugs, who found by six votes to one abstention that Qnexa could cause potential heart problems.
Qnexa was the first obesity drug submitted to the FDA in a decade.
It combines two existing drugs, the appetite suppressant phentermine and topiramate, an anti-convulsant that can be used in conjunction with other drugs for weight loss.
The FDA on October 8 requested US pharmaceutical company Abbott Laboratories to pull its obesity drug Meridia from the US market after European tests found the key ingredient increased the risk of serious heart problems.
And last week, the US health panel rejected a marketing request for 2011 for weight-loss drug Lorcaserin, made by also California-based Arena Pharmaceuticals, after tests determined it caused tumors in laboratory rats.
While a high percentage of Americans are overweight or obese, there are few medical treatments, and those on the market can have side effects including increased heart problems and intestinal gas.
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