Onglyza, known generically as saxagliptin, is a dipeptidyl peptidase-4 (DPP-4) inhibitor, used for patients who have type 2 diabetes. Concerns have been raised that the drug is linked to an increased risk of heart problems. A study, known as the SAVOR study, published in The New England Journal of Medicine, found a 27 percent increase in first event of hospitalization for heart failure in patients who took Onglyza, as well as “significant or near significant increases in all-cause mortality,” which included both cardiovascular and non-cardiovascular deaths, according to briefing materials.
Following release of the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus - Thrombolysis in Myocardial Infarction 53) study, the US Food and Drug Administration (FDA) convened an advisory panel, which recommended that the saxagliptin warning label be strengthened to include information about the risk of cardiac problems. The panel voted 13 to 1 to increase the safety warning, with one panel member reportedly finding that saxagliptin does not have an acceptable safety profile.
“The committee agreed that all-cause mortality was a fundamentally strong endpoint, and that an effect on all-cause mortality could not be ruled out,” according to minutes from the meeting. The committee also expressed concern about a potential risk for heart failure.
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In October, the FDA said it needed additional data before approving AstraZeneca’s proposed diabetes drug. The new drug, an SGLT2 inhibitor, is a combination of saxagliptin (Onglyza) and dapagliflozin, both of which are used to treat type 2 diabetes. It is not known when AstraZeneca will be able to launch the new drug, according to Bloomberg (10/15/15).
The lawsuit is case number 2015-L-010969.