FDA
15th April 2015

FDA Panel Reviews Savor Study Results For Onglyza, Kombiglyze XR

At this meeting, EMDAC was asked to review the data from SAVOR, a large, randomized, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of ONGLYZA.

FDA Panel Reviews Savor Study Results For Onglyza, Kombiglyze XR

Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13 to 1 (with 1 abstention) 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, the majority of EMDAC members recommended that the product labeling be supplemented with new safety information, while one member voted to withdraw saxagliptin from the market. The materials for this meeting can be found HERE.

At this meeting, EMDAC was asked to review the data from SAVOR, a large, randomized, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of ONGLYZA when added to current type 2 diabetes background therapy in adult patients with type 2 diabetes mellitus at risk for cardiovascular disease. Diabetes is estimated to affect 29.1 million people in the US and more than 382 million people around the world. Type 2 diabetes accounts for 90-95% of all diagnosed diabetes cases, and is a chronic disease characterized by pathophysiologic defects leading to elevated glucose levels.

ONGLYZA (saxagliptin) and KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) belong to a class of dipeptidyl peptidase-4 (DDP-4) inhibitors. DPP-4 inhibitors work by increasing the activity of incretin hormones or hormones that decrease elevated blood sugar levels. In addition to increasing incretin hormone activity, DDP-4 inhibitors increase the release of insulin when glucose levels are elevated and reduce the levels of sugar produced by the liver. Results of SAVOR showed that the primary safety objective was met, meaning ONGLYZA 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 therapy) as compared to placebo. The previously submitted supplemental New Drug Applications (sNDAs) based on the SAVOR results will provide prescribers and patients important additional information about the benefit-risk profile of ONGLYZA and KOMBIGLYZE XR, if approved.

The FDA is not bound by the Advisory Committee’s recommendation but often follows their advice.

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