Lilly/BI snag another FDA approval for a diabetes drug—Synjardy
- The FDA has approved Eli Lilly/Boehringer Ingelheim's Synjardy (empagliflozin/metformin) as a type 2 diabetes treatment. This is the fifth FDA approval for the Eli Lilly/Boehringer Ingelheim Diabetes Alliance.
- The combination of empagliflozin, an SGLT2 inhibitor, and metformin is complementary and provides two distinct approaches to lowering blood glucose (BG).
- The approval of Synjardy is based on data from multiple clinical trials showing effective BG lowering, along with a strong safety profile.
Synjardy's approval makes sense given the strength of metformin as a foundational and much relied-upon type 2 diabetes treament and the role of empagliflozin as a proven way to lower BG by removing excess glucose through the urine.
In fact, empagliflozinis marketed as monotherapy under the brand name Jardiance and is also part of Glyxambi (empagliflozin/linagliptin). It should be noted that Synjardy comes with a boxed warning regarding the risk of lactic acidosis associated with metformin accumulation.
Synjardy was approved by the European Medicines Association (EMA) in May.