Merck Blocked In Adding CV Claim For Januvia, May Fall Behind Victoza
Merck got a complete response letter from FDA on a cardiovascular risk-reduction claim for the DPP-4 inhibitor based on TECOS trial data. This places Januvia/Janumet behind Jardiance, which already has a CV safety label claim, and Victoza, which awaits an FDA decision on a supplemental NDA filed last October.
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The first large real-world evidence study has found SGLT2 inhibitors cut the rate of hospitalizations for heart failure and all-cause mortality in patients at low risk of cardiovascular events, but the results of CV outcomes studies are awaited to confirm the findings.