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FDA advisory panel: CV data needed pre-, post-approval of obesity drugs
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The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 17-6 that obesity drugs without a theoretic risk or signal for cardiovascular harm should be required to rule out a certain degree of excess cardiovascular risk.
On March 28 and 29, the committee discussed the role of CV assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.
“It’s really unacceptable that from all that we know about the potential for CV risk among patients who are obese that we wouldn’t actually look carefully for these risks,” Judith M. Kramer, MD, MS, associate professor of medicine at Duke University Medical Center, said during the meeting. “The real down side is if the CV outcome trial prolongs development and increases sample sizes to such an extent that it would inhibit the development of new products.”
But not all members were on board with this decision. William R. Hiatt, MD, FACP, professor of medicine at the University of Colorado School of Medicine, said that if a CV outcome trial is required for all obesity drugs with no signals, then the same requirement should be imposed “on all new drugs that are designed for symptomatic indications, whether it’s headaches, arthritis or anything else.”
Committee members who voted ‘yes’ had to discuss whether data should come from CV outcome trials or meta-analyses, and whether data should be obtained during pre-approval, post-approval or both. Many members believed the two-staged approach with different non-inferiority margins pre- and post-approval was the best approach.
“We don’t usually require safety studies when there’s no signal, but obesity drugs are going to be used by a very large population and there’s already some track record with them,” Erica H. Brittain, PhD, mathematical statistician of the Biostatistics Research Branch at the National Institute of Allergy and Infectious Diseases, said. “The two staged design seems like an efficient approach, and by requiring this we may find that there’s CV benefit to obesity drugs.”
The discussion focused on results of the Look AHEAD (Action for Health in Diabetes), SCOUT and CRESCENDO trials. While Look AHEAD resulted in weight loss and improvements in glycemic control and CV risk factors through intensive lifestyle intervention in patients with type 2 diabetes, results from SCOUT and CRESCENDO showed that sibutramine (Meridia, Abbott) and rimonabant (Sanofi-Aventis) were associated with increased major adverse cardiac events in patients with pre-existing CV conditions vs. placebo.
Disclosure: Drs. Brittain, Hiatt and Kramer report no relevant financial disclosures.