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CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement

 
• By Cathy Dombrowski

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.

Sponsors would have to rule out a certain level of cardiovascular risk for all obesity drugs through a CV outcomes trial, or a meta-analysis of Phase II and III major adverse cardiovascular events data, if FDA follows the March 29 recommendation of its Endocrinologic and Metabolic Drugs Advisory Committee.

The panel voted 17 to 6 in favor of such studies for drugs without a theoretic risk or signal for CV harm

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• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

More from North America

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
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