CV Events and Saxagliptin: FDA Committee Votes on Risk Profile
AstraZeneca announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has voted on the cardiovascular risk profile associated with use of Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin, metformin HCl extended-release) in patients with type 2 diabetes.
The Advisory Committee voted 13-1 that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study demonstrated that the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular risk profile. SAVOR, a large, randomized, double-blind, placebo-controlled Phase IV study in patients with type 2 diabetes at high risk of cardiovascular disease, met its primary safety objective by demonstrating that saxagliptin did not increase the risk for cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke vs. placebo. Because an increased risk for hospitalization for heart failure (hHF) was seen with saxagliptin treatment, additional research will be conducted. Fourteen out of 15 Committee members also voted to recommend that the FDA supplement the products' labeling to add new safety information.
Onglyza is indicated as adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy. Kombiglyze XR is indicated as adjunct to diet and exercise in type 2 diabetes when treatment with both saxagliptin and metformin is appropriate.
The Advisory Committee recommendation is non-binding and will be considered by the FDA.
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