Obesity Drugs Panel To Mull Whether Products Without CV Signal Need Outcomes Trial
This article was originally published in The Pink Sheet Daily
The Endocrinologic and Metabolic Drugs Advisory Committee also will evaluate methods for collecting cardiovascular risk information for obesity drugs with a CV safety signal, as FDA seeks input on when and how sponsors should evaluate their products.
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In analyses of both a narrow and a broad search for cardiovascular events in lorcaserin’s clinical trials, the upper bound of the 95% confidence level was less than 2.0, allowing marketing with a full CV outcomes trial to come post-approval, FDA briefing documents reveal.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will discuss design issues March 29 and vote on the need for pre-approval trials in drugs without a CV safety signal.
FDA appears to be testing weight loss agents against an easier-to-meet threshold for cardiovascular risk compared to diabetes drugs, based on Orexigen Therapeutics Inc.’s announcement of an agreement with the agency on a cardiovascular outcomes trial for its obesity agent Contrave (naltrexone/bupropion).