Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company announced that Synjardy (empagliflozin/metformin hydrochloride) tablets are now available by prescription in pharmacies across the United States.
The US Food and Drug Administration (FDA) approved Synjardy at the end of August 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 alone, or in patients already being treated with empagliflozin and metformin.
Synjardy is a combination of Jardiance (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.
"Boehringer Ingelheim and Lilly are committed to helping improve care for adults with type 2 diabetes," said Thomas Seck, M.D., vice president, clinical development and medical affairs - metabolism at Boehringer Ingelheim. "As part of that effort, we are proud to make Synjardy, the third product from our diabetes alliance containing Jardiance, available to patients soon after its FDA approval."
The Synjardy Simple Savings co-pay support programme is available online and in many doctors' offices for patients who qualify. Synjardy is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).
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 was 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.
Approximately 29 million Americans and an estimated 387 million people worldwide have type 1 or type 2 diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. T2D is the most common type, accounting for an estimated 90 to 95 per cent 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.