FDA approves supplemental NDA for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) in type 2 diabetes care- Boehringer and Eli Lilly

The FDA 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.

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.