FDA approves new weight loss pill

WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite achieving only 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 yesterday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

In 2010, the FDA denied approval for Arena's drug 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 Belviq in early 2013.

But a long line of prescription weight loss offerings has been associated with safety problems, most notably fen-phen, 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.

The FDA said in a news release that Belviq "does not appear to activate" a chemical pathway linked to heart problems seen with fen-phen.