FDA Approves Weight loss Pill, First Time in 13 Years - Daily Disruption

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Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BELVIQ (pronounced BEL-VEEK), the first of its kind in 13 years. It’s not the magic pill most who diet are always looking for, you still need to eat a reduced-calorie diet and increase your physical activity. But it could be a very useful aide for chronic weight management in obese or overweight adults including those who suffer from at least one weight related issues such as hypertension, dyslipidemia, and type 2 diabetes. Jack Lief, Arena’s President and Chief Executive Officer said,

“The FDA approval of BELVIQ is an important development for patients who struggle with obesity or are overweight with comorbidities and need help with chronic weight management beyond diet and exercise.” He went on to say, ”We thank our entire team and the patients who participated in our clinical trial program for making this achievement possible.”

The clinical trials show that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years.

“Diet, exercise and behavioral therapy alone may not result in sustained weight loss for many overweight and obese people trying to lose weight,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “BELVIQ represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese.”

The FDA has recommended that BELVIQ be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review the FDA’s recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when BELVIQ will be available to patients and physicians in the United States.

Arena will manufacture and supply the finished commercial product from its facility in Switzerland, and Eisai will market and distribute BELVIQ in the United States.

SOURCE Arena Pharmaceuticals, Inc.