FDA approves Synjardy for type 2 diabetes

August 31, 2015

FDA has approved empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) tablets for the treatment of adults with type 2 diabetes.

FDA has approved empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) tablets for the treatment of adults with type 2 diabetes (T2D).

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Diabetes is a metabolic condition that occurs because of the body’s inability to either produce or use the hormone, insulin, which leads to high blood glucose levels.  An estimated 29 million Americans currently have type 1 diabetes (T1D) or T2D. T2D, a condition in which the body does not utilize insulin properly, is the most common type, accounting for approximately 90% to 95% of all diagnosed adult diabetes patients in the United States.

Synjardy is a combination of empagliflozin and metformin used to help control blood glucose in patients with T2D. Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor, which reduces reabsorption of filtered glucose in the kidney thereby increasing urinary excretion of glucose and decreasing plasma glucose concentrations. Metformin acts to lower plasma glucose levels by decreasing its production in the liver as well as decreasing its absorption in the intestine.

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Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with empagliflozin and metformin as separate medications. The FDA approval of Synjardy was based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with a sulfonylurea, in the treatment of T2D.

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

The most common side effects associated with the use of Synjardy include stuffy or runny nose and sore throat, urinary tract infections, diarrhea, headache, nausea and vomiting. Synjardy’s label does contain a boxed warning as metformin can cause lactic acidosis, a rare but potentially fatal metabolic complication. Synjardy is not for the treatment of T1D or diabetic ketoacidosis. 

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