Boehringer Ingelheim Pharmaceuticals, Inc., one of the world's 20 leading pharmaceutical companies, (BIPI) and Eli Lilly and Company, a global healthcare leader, announced that the US Food and Drug Administration (FDA) has approved Synjardy (empagliflozin and metformin hydrochloride) tablets 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) and Glyxambi (empagliflozin/linagliptin).

Synjardy is a combination of empagliflozin and metformin — two medicines with complementary mechanisms of action — to help control blood glucose in people with T2D. 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 T2D, lowers glucose production by the liver and its absorption in the intestine.

"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."

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. Synjardy is not for the treatment of type 1 diabetes or diabetic ketoacidosis.

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 with  Synjardy.

The FDA approval of Synjardy is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with T2D.

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

Approximately 29 million Americans and an estimated 387 million people worldwide have type 1 or type 2 diabetes, and nearly 28 per cent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the US, approximately 12 per cent of those aged 20 and older have diabetes. T2D is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the US. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.