FDA OKs first obesity drug in 13 years

Last Updated: 2012-06-27 16:05:20 -0400 (Reuters Health)

By Bill Berkrot and Anna Yukhananov

NEW YORK/WASHINGTON (Reuters) - U.S. health regulators on Wednesday approved Arena Pharmaceuticals Inc's pill to treat obesity, making it the first new weight-loss drug in 13 years as public health advocates push for new solutions to the nation's growing obesity epidemic.

Arena's lorcaserin, which will be sold under the brand name Belviq, was one of three experimental weight-loss drugs seeking U.S. Food and Drug Administration approval after initial rejections by the agency. Vivus Inc and Orexigen Therapeutics Inc are still hoping to bring their medicines to market.

The Arena drug is approved for use in adults with a body mass index (BMI) of 30 or greater, which is considered obese, or adults with a BMI of 27 or greater - overweight - and who have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol. BMI is a measure of weight in relation to height.

As part of the approval, Arena will be required to conduct six post-marketing studies, including a long-term heart study to assess whether Belviq increases the risk of heart attack or stroke, the agency said in announcing its decision.

The FDA first rejected lorcaserin, which was developed in partnership with Japanese drugmaker Eisai Co Ltd, in October 2010, citing potential cancer risks. Arena resubmitted its application with more data to show that the previous findings of tumors in rats did not apply to people, which seemed to soothe some of the FDA's concerns.

Eisai will sell Belviq in the United States.

An advisory panel to the FDA in May voted to recommend approval of lorcaserin, saying that its benefits outweighed the risks despite voicing some concerns about potential heart risks.

The FDA, knowing that millions of Americans would be tempted to take weight loss pills, had set a very high bar for approvals because of serious safety problems seen in the past with medicines in the category.

But with some two-thirds of Americans considered overweight and half of them obese, the agency has been under mounting pressure to approve a new weight loss treatment.

"Obesity threatens the overall well being of patients and is a major public health concern," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "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 infamous diet drug combination known as "fen-phen" was pulled from the market in 1997 after it was found to cause heart valve damage.

Meridia, another diet pill, was pulled from the U.S. market in 2010 after being linked to heart problems, leaving Roche Holding AG's Xenical as the only prescription obesity drug approved for long-term use. Its side effects and limited effectiveness have made it far less than an optimal choice to tackle the obesity epidemic.

Patients in pivotal trials of Arena's drug on average lost about five percent of body weight. It is designed to block appetite signals in the brain to help people feel full after eating smaller amounts of food.