The FDA is reviewing trial data for the diabetes drug saxagliptin after a published study found an increased rate of hospitalization for heart failure with treatment.
Saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) is a dipeptidyl peptidase-4 (DPP-4) inhibitor that was approved by the FDA in 2009. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Last year, is sponsors Bristol-Myers Squibb and AstraZeneca reported saxagliptin failed to meet its primary efficacy endpoint in the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial. The FDA said it asked the sponsors to provide SAVOR data after a study published in the New England Journal of Medicine reported that 3.5 percent of patients in the saxagliptin group were hospitalized for heart failure compared with 2.8 percent in the placebo group.
There were no increased rates of death or other major cardiovascular risks associated with saxagliptin, according to the FDA.
“At this time, we consider information from the NEJM study to be preliminary,” the FDA wrote in a safety announcement. “Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.”
The agency encouraged patients to continue taking the medication and to speak with their physicians about concerns.