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Merck Blocked In Adding CV Claim For Januvia, May Fall Behind Victoza

 
• By Joseph Haas

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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Merck & Co. Inc.'s diabetes franchise took a major blow April 7 when the firm announced that its supplemental new drug application to add a cardiovascular outcomes claim to the labels for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) received a complete response letter.

The New Jersey pharma offered no details on the CRL, other than to say it is reviewing the letter and will discuss "next steps" with the US FDA.

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