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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