MOUNTAIN VIEW, Calif. The Food and Drug Administration has accepted a regulatory approval application for a drug to treat obesity, according to the company that makes the drug.
VIVUS announced Monday that the FDA had accepted its application for Qnexa. The company expects the agency’s review of the drug to be finished by Oct. 28.
According to placebo-controlled phase 3 trials of Qnexa, the drug helped patients lose weight while also helping cardiovascular, inflammatory and metabolic risk factors.
“The FDA’s acceptance of the Qnexa [application] marks an important milestone in the development of Qnexa as a treatment for patients who are obese or overweight with co-morbidities,” VIVUS CEO Leland Wilson stated. “We believe that Qnexa, if approved, will play an important role in treating the millions of patients living with obesity and related disease and who are in need of safe and effective options.”