FDA approves Boehringer Ingelheim, Eli Lilly’s Synjardy

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RIDGEFIELD, Conn., and INDIANAPOLIS — Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. have received approval from the Food and Drug Administration for Synjardy tablets, a medication for type 2 diabetes.

The companies said Thursday that Synjardy (empagliflozin and metformin hydrochloride) marks their third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).

Synjardy helps control blood glucose in adults with type 2 diabetes. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.

Specifically, Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with empagliflozin and metformin.

The Synjardy label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment.

“Synjardy is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last four years,” stated Paul Fonteyne, president and chief executive officer of Boehringer Ingelheim. “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.”

Synjardy was also approved by the European Medicines Agency in May 2015.


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