FDA panel favors heart failure warning on saxagliptin’s labeling

An FDA advisory panel recommended that labeling for the diabetes drug saxagliptin include a warning about a risk of heart failure. The panel determined that the drug’s overall cardiovascular risk was acceptable.

The Endocrinologic and Metabolic Drugs Advisory Committee reviewed results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial, a postmarketing study that was designed to evaluate the cardiovascular effects of saxaglipin (Onglyza, AstraZeneca). The FDA approved saxagliptin in 2009 as a treatment to control high blood sugar levels in patients with type 2 diabetes.

The FDA had requested more research on saxagliptin after the SAVOR TIMI 53 trial, published in 2013, found it neither reduced nor increased the rate of ischemic events; researchers also noted an increase in the rate of heart failure hospitalization with saxagliptin.

The safety data in the postmarketing showed no increase in the risk of cardiovascular death, nonfatal MI and nonfatal ischemic stroke when added to current standard care, with or without other diabetes therapies, compared to placebo. The panel voted 13-1 with one abstention that saxaglipin had an acceptable cardiovascular risk profile.

One member voted to withdraw saxagliptin from the market and the remaining 14 panelists recommended the labeling change to include the heart failure warning.

The FDA often but not always follows the recommendations of its advisory panels.