FDA hands Vivus a complete response letter for Qnexa

FDA today issued a complete response letter for Vivus' Qnexa, one of three closely-watched obesity drugs up for approval.

Just days after rejecting Arena's obesity drug lorcaserin, the FDA today issued a complete response letter for Vivus' Qnexa, one of three closely-watched obesity drugs up for approval. Previously, an expert panel voted 10 to 6 against approval of the drug, with many panel members seeking more safety data for Qnexa.

The CRL included the following areas, according to the Vivus (NASDAQ: VVUS) release: clinical, labeling, REMS, safety update, and drug scheduling. Specifically, the FDA wants a detailed plan to handle the risks Qnexa may present to women who are pregnant or may become pregnant. The agency also want data proving that elevated heart rate associated with the drug doesn't lead to cardiovascular problems. Vivus will have to provide results from an already completed 52-week study of the drug, an extension study for a subset of 675 patients who completed the CONQUER study. FDA requested continued discussion of Vivus' already-submitted REMS plan. Finally, the agency asked