FDA shoots down Merck's bid to add lack of heart risks to Januvia's label

Fierce Pharma ------- With diabetes rivals coming up with heart-helping outcomes data, Merck at least wants data on its label showing its Januvia doesn’t hurt heart health. U.S. regulators, though, say not so fast. Friday, they hit the New Jersey drugmaker with a complete response letter rejecting Merck’s sNDAs for Januvia and related combos Janumet and Janumet XR. The company had sought to add results from its TECOS outcomes trial—a heart study that turned up no red flags—to all three drugs. “Merck is reviewing the letter and will discuss next steps with the FDA,” it said in a statement. To learn more click on the picture below to read the article.