FDA approves Synjardy tablets

RIDGEFIELD, Conn. and INDIANAPOLIS — The Food and Drug Administration has a new diabetes treatment developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Co. Synjardy (empagliflozin and metformin hydrochloride) is the third product containing empagliflozin for the treatment of adults with type 2 diabetes to be approved by the FDA.

"Synjardy is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last four years," Paul Fonteyne, president and CEO of Boehringer Ingelheim, said. "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."

An adjunct to diet and exercise, Synjardy combines empagliflozin and metformin — two medicines with complementary mechanisms of action — to help control type 2 diabetes patients’ blood glucose, according to Boehringer Ingelheim. Empagliflozin, a sodium glucose co-transporter-2 inhibitor, removes excess glucose through the urine by blocking glucose reabsorption in the kidney, while metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.

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