FDA Panel Overwhelmingly Backs Approval Of Anti-Obesity Pill
SILVER SPRING, Md. (AP) — A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill from Vivus Inc., a drug which the FDA previously rejected due to safety concerns.
The FDA panel of outside physicians voted 20-2 in favor of the weight loss drug Qnexa, setting the stage for a potential comeback for a drug that has been plagued by side effects since it was first submitted to the agency in 2010.
A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients reporting nearly 10 percent weight loss. But the group stressed the importance of confirming the drug’s safety, particularly its effects the heart, by tracking patients in a large, follow-up study. FDA’s decision is expected in April.