ONGLYZA/KOMBIGLYZE

Onglyza (saxagliptin)
Kombiglyze (saxagliptin and metformin)

Dipeptidyl peptidase-4 (DPP-4) inhibitor

Type 2 diabetes

Heart failure

Onglyza and Kombiglyze are used to help control high blood sugar in patients with type 2 diabetes. These drugs were developed by Bristol-Myers Squibb (BMS) and in 2007, AstraZeneca joined with BMS to market the drugs. The Food and Drug Administration (FDA) approved Onglyza in July 2009 and Kombiglyze in November 2010.

In February 2014, the FDA requested additional data from the manufacturer of these drugs based on a study published in the New England Journal of Medicine (NEJM) that reported an increased rate of hospitalization for heart failure. In April 2015, after reviewing the data, an FDA Advisory Committee voted 14 to 1 to add a new heart failure warning to the drug label. The one person who voted against the label change wanted to pull the drug from the market.