FDA committee recommends approval for obesity drug
MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.
Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.
"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," Vivus president Peter Tam said. "We look forward to working with the FDA as they complete their evaluation."
The FDA originally accepted Vivus' regulatory application for Qnexa in February 2010, but the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against recommending approval in July of that year, citing concerns over the safety of the drug. In October 2010, the FDA issued a complete response letter, a notice that it had declined to approve the drug, and requested additional clinical study data.