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FDA approves Synjardy for type 2 diabetes
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The FDA has approved Synjardy to control blood glucose levels in adults with type 2 diabetes, according to a release from Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company.
Synjardy (empagliflozin and metformin hydrochloride) is the third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).
"Synjardy is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last 4 years," Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, said in a statement. "No two people with diabetes are alike, and every experience is different. Our alliance is proud to offer a diverse portfolio of treatments that can help patients throughout their diabetes journey."
Empagliflozin, an SGLT2 inhibitor, removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Synjardy was approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes that is not adequately controlled with either empagliflozin or metformin alone, or in patients already being treated with both.
The therapy is not designed for people with type 1 diabetes or diabetic ketoacidosis. The drug contains a Boxed Warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment.
The FDA approval of empagliflozin and metformin combination therapy is based on the results of multiple clinical trials examining the coadministration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes.
Synjardy was approved by the European Medicines Agency in May.