FDA panel backs Qnexa
FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 on Wednesday that the benefit-risk profile for Qnexa from Vivus Inc. (NASDAQ:VVUS) supports approval to treat obesity. The panel agreed the efficacy of the fixed-dose combination of phentermine and topiramate in the Phase III program outweighed potential cardiovascular and teratogenic risks. Qnexa has an April 17 PDUFA date. Trading in Vivus was halted on Wednesday. In early after-hours trading, the stock was up $10.36 (98%) to $20.91.
In the Phase III program, Qnexa led to a mean weight loss from baseline of up to 11% but was associated with a heart rate increase of up to 1.6 beats per minute over placebo. Patients on placebo had a mean weight loss of up to 1.8%. Panel members felt that due to the substantial improvement in weight loss, a cardiovascular outcomes trial could be conducted post-approval to characterize Qnexa's potential risks. ...