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Obesity Drugs’ CV Risk Assessment Needs Hard Endpoints, Panel Tells FDA

Executive Summary

When CV risk is assessed both before and after an obesity drug is approved, the first assessment could include subjectively determined events in the endpoint, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said during a session that included a vote in favor of outcomes trials for weight-loss drugs without a CV safety signal.

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Agency officials viewed the review of canagliflozin – the first program started after the 2008 outcomes trial requirement – as a chance to look at lessons learned since the policy went into effect.

FDA Used Invokana Review To Reflect On Diabetes CV Risk Policy

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