FDA panel backs label changes to DPP-4 inhibitors

FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended on Tuesday that the agency add language about potential risks of heart failure to the labels of two DPP-4 inhibitors to treat diabetes -- Onglyza saxagliptin from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Nesina alogliptin from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).

The recommendations came after the panel analyzed the data from two cardiovascular outcomes trials, SAVOR for Onglyza and EXAMINE for Nesina. ...