FDA committee green-lights adult obesity drug
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended Vivus' Qnexa (phentermine and topiramate) be granted marketing approval by the FDA for the treatment of obesity in adults. The committee voted 20 to two, on the recommendation for an approval based on a favorable benefit-risk profile.
"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, president of Mountain View, Calif.-based Vivus. "We look forward to working with the FDA as they complete their evaluation."
The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the new drug application that was submitted for Qnexa in October 2011. The scheduled date of Prescription Drug User Fee Act for Qnexa is April 17.
Qnexa is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. The company said that Qnexa is a once-a-day, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety—the two main mechanisms that impact eating behavior.
"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, president of Mountain View, Calif.-based Vivus. "We look forward to working with the FDA as they complete their evaluation."
The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the new drug application that was submitted for Qnexa in October 2011. The scheduled date of Prescription Drug User Fee Act for Qnexa is April 17.
Qnexa is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. The company said that Qnexa is a once-a-day, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety—the two main mechanisms that impact eating behavior.