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Can A Safety Study Support A Superiority Claim? Barely, FDA Advisors Say

FDA advisory committee narrowly endorses CV mortality benefit claim for Boehringer/Lilly's diabetes drug Jardiance, but some panelists question wisdom of relying on study originally designed for cardiovascular safety to support a post-marketing superiority claim.

Using a clinical trial originally designed for safety to support an efficacy superiority claim poses unique challenges that can make reliance upon a single study for regulatory purposes potentially risky.

That was one take-home message from the FDA Endocrinologic and Metabolic Drugs Advisory Committee's June 28 review of the EMPA-REG OUTCOME trial's results to support a cardiovascular mortality benefit claim for Boehringer Ingelheim GMBH and

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