FDA May Require Heart Studies For Latest Weight Loss Drugs

As we’ve previously reported, the weight loss industry is on the edge of a break through with the latest obesity drugs that are scheduled to hit the market soon.  They will be the first of their kind in over a decade, but they may not be ready just quite yet.  The FDA may first require heart studies, according to a number of media reports.

According to Reuters, U.S. health regulators are asking for advice on whether, and when, heart safety studies should be required for new obesity drugs, possibly adding a new hurdle on their path to approval.

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.

While Contrave by Orexigen Therapeutics Inc. still has several more years of trials ahead.

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, but it generally does.



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