FDA nixes Merck’s shot at getting Januvia cardio safety data onto the label
Merck is not going to get any help from the FDA in marketing its big diabetes drug Januvia.
A $6 billion earner last year, Merck’s flagship DPP-4 drug came out of a massive 14,724-patient study in 2015 with data demonstrating that Type 2 patients could take this drug without raising their risk for cardio complications. Merck wanted that in the label to help distinguish themselves from same-class rivals like Onglyza, which has risks, but the FDA nixed the idea, handing the pharma giant a complete response letter.
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