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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...

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