FDA May Require Heart Studies for New Obesity Drugs

The U.S. Food and Drug Administration (FDA) may mandate heart studies for new obesity drugs, according to a number of media reports.

Three California firms—Vivius Inc, Orexigen Therapeutics Inc., and Arena Pharmaceuticals Inc.—are currently vying for approval of their new weight-loss pills—the first in over a decade, said Bloomberg.com. A decision is expected by the FDA on Vivus’ drug Qnexa by April 17 and Arena’s drug, lorcaserin, goes before an advisory panel on May 10. An advisory panel is scheduled to conduct a hearing on the drugs in Silver Spring, Maryland, beginning March 28, said Bloomberg.com.

Contrave by Orexigen Therapeutics Inc. is facing several years of clinical trials, said Fox News.

The panel will decide if “obesity drugs without a theoretic risk or signal for” cardiovascular harm “should be required to rule out” some form of cardiovascular risk prior to approval, said FDA staff. The agency is not required to adhere to panel recommendations, said Bloomberg.com, but generally does.

The possible drug approvals come after 15 years following removal of fen-phen. An appetite suppressant, the fen-phen drug combination was pulled in 1997 from pharmacies after being linked to heart-valve abnormalities, Bloomberg.com explained. The last obesity drug to be approved by the FDA was Xenical, made by Roche Holding AG, and approved in 1999. In 2010, Abbott Laboratories pulled its weight-loss drug Meridia from the U.S. after a study revealed it increased heart attack and stroke risks in some patients, said Fox News.

Arena’s new diet drug application was accepted today by European regulators, it said, wrote Bloomberg.com. Also an analysis conducted by Vivus on Qnexa’s risks was “somewhat reassuring”; however, the significance of a heart rate increase was “uncertain,” said FDA staff in a February 17 report, according to Bloomberg.com.

“Obesity affects millions of people in the United States and increases the risk of premature death and cardiovascular disease,” FDA staff said. “Thus, the cardiovascular assessment of drugs developed for the treatment of obesity is an important public health issue,” wrote Fox News. The reviewers, in advance of Wednesday’s meeting, will weight potential heart health benefits from weight loss versus heart problems seen in clinical studies of weight loss drugs.

Vivus has proposed a post-approval trial to review Qnexa in reducing major heart complications in obese, at-risk patients and would involve 11,300 patients over four and a-half years, said Bloomberg.com. Orexigen agreed with the FDA in September to conduct a two-year study of heart risks for Contrave and will utilize less than 10,000 patients. Orexigen is partnered with Takeda Pharmaceutical Co. Arena is studying lorcaserin for cancer risks and has partnered with Eisai Co.

The FDA, which also mandates makers of type 2 diabetes drugs to study heart risks pre-approval regardless of risk signals—previously rejected the three weight loss drugs, asking for additional information safety risks, including the possibility of birth defects linked to Qnexa.

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