CardioExchange Archive

The FDA announced today that it has approved its first new weight loss drug in 13 years. Lorcaserin, which will be sold under the brand name of Belviq, is manufactured by Arena Pharmaceuticals and will be distributed in the U.S. by Eisai.

Lorcaserin is indicated for use in obese adults (BMI 30 or above), or overweight adults (BMI 27 or above) with a coexisting weight-related condition such as hypertension, diabetes, or high cholesterol.

“Obesity threatens the overall well being of patients and is a major public health concern,” said the FDA’s Janet Woodcock, in an FDA press 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.”

The FDA is requiring Arena to conduct six postmarketing studies, including a long-term CV outcomes trial. The label will note that the effects of lorcaserin on cardiovascular morbidity and mortality have not been established and that its safety and efficacy when used with other weight-loss drugs has not been tested. During a press conference, the company said that Drug Enforcement Administration (DEA) scheduling normally takes from 4 to 6 months, indicating that the drug might not become available this year.

Arena said that the FDA has recommended to the DEA that lorcaserin be classified as a scheduled drug. The drug will not be available until after the DEA reviews the recommendation and decides whether the drug will be scheduled.