The FDA cleared Belviq for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
WASHINGTON — The Food and Drug Administration (FDA) has approved the anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in more than a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA’s endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena Pharmaceutical’s drug in 2010 after scientists raised concerns about tumors that developed in animals. The company resubmitted the drug with additional data this year, and the FDA said there was little risk of tumors in humans.
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With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight-loss treatments.
But a long line of prescription weight-loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart-valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight-loss combination prescribed by doctors, though it was never approved by FDA.
Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.
Qnexa is thought to be the most promising of the drugs, but the FDA has delayed a decision on that pill until July.