FDA Declines To Issue “Cardio-Protective” New Label Claim For Merck’s Januvia®/Janumet®…

This is a disappointment for Kenilworth, no doubt. But Merck will discuss with FDA — about next steps, on a path forward.

I am not at all certain the company will ultimately secure that label claim, though. And all that really means is that Januvia®/ Janumet® will not see quite the market expansion it might have otherwise seen. So it goes. Here’s a bit of the news:

. . . .Merck is down 2% premarket on average volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Applications seeking to add cardiovascular outcomes data from the TECOS study to the labels of JANUVIA (sitagliptin), JANUMET (sitagliptin and metformin HCl) and JANUMET XR (sitagliptin and metformin HCl extended-release).

Results from TECOS showed JANUVIA to be non-inferior to placebo in cardiovascular risk.

The company says it is reviewing the letter and will discuss next step with the agency. . . .

Now you know. Onward — clear and icy, hard and cold.



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