FDA APPROVES NEW OBESITY DRUG

Marion Pellicano Ambrose



The Food and Drug Administration has approved a new anti obesity drug names Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in 13 years.

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 , high cholesterol .or high blood pressure.

The FDA denied approval for the drug in 2010 after scientists raised concerns about tumors that developed in animals studied. The company resubmitted the drug with additional data, and the FDA said there was little risk of tumors in humans.

Arena, the pharmaceutical company who manufactures the drug, and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch Belviq early next year.

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.

In a rare move, the FDA explicitly stated that Belviq “does not appear to activate” a chemical pathway that was linked to the heart problems seen with fen-phen. It said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of fullness. With obesity on the rise in America, I’m sure there are many overweight people hoping that this might finally be the magic pill that will end their struggles with see-sawing weight and the accompanying health problems. Let’s hope this drug does all they say it will do.

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