Diabetes Drug Labels Should Reflect Heart Failure Risk, FDA Panel Says

Advisory committee endorses CV ischemic safety of AstraZeneca’s saxagliptin and Takeda’s alogliptin but recommends safety-related revisions to the labels of both DPP-4 inhibitors.

Cardiovascular outcomes trial results for AstraZeneca PLC’s Onglyza (saxagliptin) and Takeda Pharmaceuticals USA Inc.’s Nesina (alogliptin) warrant new safety-related labeling for the diabetes drugs, but not distribution restrictions or market withdrawal, an FDA advisory committee said April 14.

In separate votes, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee overwhelmingly recommended labeling changes for saxagliptin and alogliptin to reflect...

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