FDA Approves Synjardy XR for Adults With Type-2 Diabetes

Extended-release tablet contains empagliflozin and metformin

The FDA has given the green light to Synjardy XR (empagliflozin and metformin hydrochloride extended-release tablets, Boehringer Ingelheim/Lilly) for the treatment of adults with type 2 diabetes (T2D). When used along with diet and exercise, Synjardy XR is indicated to improve blood sugar in adults with T2D when both empagliflozin and metformin can be taken.

Standard Synjardy tablets were approved in 2015.

Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Synjardy XR is the fourth FDA-approved treatment that contains empagliflozin. Metformin, a commonly prescribed initial treatment forT2D, lowers glucose production by the liver and its absorption in the intestine.

The FDA’s approval of Synjardy XR was based on results from several clinical trials that examined the coadministration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults withT2D. Synjardy XR is not indicated for the treatment of type-1 diabetes or diabetic ketoacidosis.

Metformin can cause lactic acidosis, a rare but serious condition that can result in death. Lactic acidosis is a medical emergency and must be treated in a hospital. Synjardy XR can cause dehydration, hypotension, and ketoacidosis.

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28% of Americans with diabetes—totaling eight million people—are undiagnosed. In the United States, approximately 12% of individuals 20 years of age and older have diabetes. T2D is the most common type, accounting for an estimated 90% to 95% of all cases of diagnosed adult diabetes in the U.S.

Source: Eli Lilly; December 12, 2016.