FDA Approves Supplemental New Drug Applications to Include New Data in Product Labels for Synjardy®,

The U.S. Food and Drug Administration has approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME® trial. The data show that empagliflozin reduced the risk for cardiovascular death compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. The data have been added to the "Clinical Studies" sections of the Prescribing Information for Synjardy® (empagliflozin/metformin hydrochloride), Synjardy®XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi® (empagliflozin/linagliptin) tablets, all of which are marketed by Boehringer Ingelheim and Eli Lilly and Company. SYNJARDY, SYNJARDY XR and GLYXAMBI are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Empagliflozin, a component of these medicines, is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. However, the effectiveness of SYNJARDY, SYNJARDY XR and GLYXAMBI on reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease has not been established.

"The addition of these data to the SYNJARDY, SYNJARDY XR and GLYXAMBI labels will help physicians better understand the available clinical trial evidence to help their patients who have type 2 diabetes and cardiovascular disease," said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs, Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. "As part of our long-standing and continuing efforts to help adults with type 2 diabetes, we are pleased that our discussions with the FDA have resulted in these important label updates."