Will CV Verdicts For Onglyza, Nesina Cause FDA To Change Its Tune On Antidiabetic Safety?

Two large studies finding neutral cardiovascular impacts with DPP-4 inhibitors have invigorated debate over FDA’s nearly five-year-old requirement for CV outcomes data for all new type 2 diabetes drugs.

Given CV safety findings from the SAVOR study of Bristol-Myers Squibb Co./AstraZeneca PLC’s Onglyza (saxagliptin) and the EXAMINE trial of Takeda Pharmaceutical Co. Ltd.’s Nesina (alogliptin), FDA...