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FDA Approves First New Weight-Loss Drug in More Than a Decade
Date:6/27/2012

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, June 27 (HealthDay News) -- The first new weight-loss drug in 13 years was approved Wednesday by the U.S. Food and Drug Administration.

The drug, Belviq (lorcaserin), was approved for obese adults who have high blood pressure, high cholesterol or type 2 diabetes, and is to be used in combination with a low-calorie diet and exercise, the FDA said.

"Obesity threatens the overall well-being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency news release. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."

However, Dr. David L. Katz, director of Yale University's Prevention Research Center, said that even the best weight-loss drugs can do little to reverse a problem now affecting much of the population.

"Belviq is unlikely to rank among the best of drugs," he said. "While it is better than placebo at fostering weight loss, its effects appear to be modest. And while trial results are reassuring so far, there are still concerns about a potential for damage to heart valves seen with drugs of this kind."

Right now there is no information of the cost of the Belviq, said David Schull, a spokesman for Arena Pharmaceuticals GmbH of Zofingen, Switzerland, the maker of the drug. It will be distributed in the United States by Eisai Inc., of Woodcliff Lake, N.J.

"Eisai will launch the drug after the Drug Enforcement Administration completes its scheduling," he said. "More information will follow as Eisai moves toward launch."

This isn't the first time Belviq was up for FDA approval. In 2010, Arena sought approval but was turned down because animal studies showed the drug was associate
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