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FDA Advisors Recommend New Safety Information for Saxagliptin (Onglyza) Label
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted 13 to 1 (1 abstained; 15 total votes) that the results of the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus) study demonstrated that the use of saxagliptin (Onglyza, Astra Zeneca) in patients with type-2 diabetes has a “broadly 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. The recommendation did not include any restrictions on prescribing the drug.
“We believe the FDA will view the risk as likely to be a class effect and apply changes to all approved drugs in the class,” said Richard Parkes, an analyst at Deutsche Bank, in a research note. “Thus, even with information added to Onglyza’s label for increased risk of heart failure hospitalization, we do not expect the drug to be commercially disadvantaged versus other members of its class.”
The advisory committee was asked to consider data from the postmarketing SAVOR trial –– a large, randomized, double-blind, placebo-controlled study designed to evaluate the cardiovascular effects of saxagliptin when added to current type-2 diabetes background therapy in more than 16,000 adult patients with type-2 diabetes mellitus at risk for cardiovascular disease.
The study met its primary safety objective, demonstrating that saxagliptin did not increase the risk for cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke when added to a patient’s current standard of care, with or without other antidiabetic therapies, compared with placebo.
In December 2008, the FDA issued guidance requiring drug companies to conduct long-term studies to show that new diabetes drugs do not increase cardiovascular risk.
Sources: AstraZeneca; April 14, 2015; and Reuters; April 14, 2015.