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Empagliflozin/Metformin Combo Tablet Wins FDA Nod for Adults With Type-2 Diabetes

Approval based on clinical trials showing reduced blood glucose versus placebo

The FDA has approved Synjardy (empagliflozin and metformin hydrochloride tablets, Boehringer Ingelheim/Eli Lilly) for the treatment of adults with type-2 diabetes (T2D). Synjardy is the third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin, Boehringer Ingelheim) and Glyxambi (empagliflozin/linagliptin, Boehringer Ingelheim/Eli Lilly).

Synjardy is a combination of empagliflozin and metformin — two medications with complementary mechanisms of action — to help control blood glucose in patients with T2D. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.

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. The treatment is not intended for patients with type-1 diabetes (T1D) or diabetic ketoacidosis.

The labeling for Synjardy includes a boxed warning regarding the risk of lactic acidosis, a serious metabolic complication that can occur as a result of the accumulation of metformin during treatment with Synjardy.

The FDA’s approval of Synjardy was based on results from multiple clinical trials that examined the coadministration of empagliflozin and metformin, alone or in combination with sulfonylurea, in adults with T2D.

Approximately 29 million Americans and an estimated 387 million people worldwide have T1D or T2D, and nearly 28% of Americans with diabetes — totaling 8 million people — are undiagnosed. In the U.S., approximately 12% of those aged 20 years and older have diabetes. T2D is the most common type, accounting for an estimated 90% to 95% of all diagnosed adult diabetes cases in the U.S. 

Source: Eli Lilly; August 27, 2015.


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