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 drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O’Neil said he’s encouraged by the drug’s approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
“This is good news because it tells us that the FDA is indeed treating obesity seriously,” said O’Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. “On the other hand, it’s not the answer to the problem — or even a big part of the answer.”
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
“The way these things tend to work is you have some people who do extremely well and other people don’t lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field,” said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.
The FDA denied approval for Arena’s drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
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 the FDA.
In a rare move, the FDA explicitly stated in a press release that Belviq “does not appear to activate” a chemical pathway that was linked to the heart problems seen with fen-phen.
The FDA said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.
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.
Vivus Inc.’s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. But the FDA has delayed a decision on that pill until July.