Obesity drug developers have gotten rained on in recent journeys to the FDA. So developer Vivus' ($VVUS) news yesterday that the agency has accepted its latest bid for approval of the weight-loss drug Qnexa offers a welcomed break in the clouds for the field. The company also published a batch of data from a one-year study that show that patients on the drug lost weight while getting other health benefits.
After announcing last month that it had filed another new drug application with U.S. regulators for the drug, Vivus said yesterday that the FDA had given the firm a 6-month review period on its application and that a panel of non-FDA experts will weigh in on the drug's approvability in the first quarter of 2012. That puts Vivus in the lead among biotechs such as Arena Pharmaceuticals and Orexigen Therapeutics that are in the late stages of developing obesity drugs and, of course, are hungry for approvals.
Vivus also published some data in the journal Obesity. In the firm's one-year study, called "Equip," obese patients on Qnexa, which is the firm's pill that combines phentermine and topiramate, had average weight loss of 14.4% and investigators saw upbeat trends in blood pressure, glucose, levels of fat in blood and cholesterol. These data all point to a potential benefit of providing severely obese patients a treatment option that doesn't require surgery.
With regulators taking a firm stance on side-effect risks of obesity drugs, Vivus is asking for the agency to approve its drug with a restriction on usage among women who could become pregnant. Last year, the FDA sent the company packing with its application, asking for data on potential heart safety risks of its treatment, Reuters reported.
- here's the FDA-related release
- read the clinical data release
- see the Reuters article
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