FDA Advisory Committee considers that Onglyza (saxagliptin) has an acceptable CV risk profile.-AstraZeneca

AstraZeneca announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13 to 1 (1 abstained; 15 total votes) 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. In addition, 14 out of 15 Committee members recommended that the FDA supplement the products’ labeling to add new safety information, with one vote to withdraw saxagliptin from the market.