FDA Approves Glyxambi for Patients with Type 2 Diabetes

US health regulators have approved a first-of-its-kind diabetes treatment, which combines two existing drugs in one tablet.

The US Food and Drug Administration (FDA) has approved Eli Lilly and Co and Boehringer Ingelheim Pharmaceuticals’ Glyxambi (empagliflozin/linagliptin) tablets, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.

This is the first treatment in the US to combine the dual mechanisms of action of a sodium glucose co-transporter-2 (SGLT-2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet taken in the morning. SGLT2 inhibitors remove glucose through the urine by blocking re-absorption of blood glucose in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

The FDA’s approval was based on a phase III clinical trial that evaluated the efficacy and safety of the drug compared with empagliflozin or linagliptin in adults with T2D who were also taking high-dose metformin. In the trial, Glyxambi was more effective in lowering blood-sugar levels than either drug alone.

“Today’s medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control,” said Paul Ponteyne, president and CEO, BIPI. “With Glyxambi, the dual inhibitor of DPP-4 and SGLT2 – two proven targets in the treatment of type 2 diabetes – now provides US physicians and patients with an option to simultaneously address multiple pathways to improve glycemic control. For patients uncontrolled on metformin, phase III trial results showed Glyxambi provided significantly greater reductions in blood glucose levels compared with either empagliflozin or linagliptin alone.”

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 eight million people, are undiagnosed. T2D is the most common type, accounting for an estimated 90-95 percent of all adult diabetes cases in the US.

“Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever,” said Mike Mason, vice president, US, Lilly Diabetes.  “The approval of Glyxambi gives US physicians and patients a first-in-class prescription medicine to help manage this condition. The approval is also a testament to our alliance’s commitment to adults living with type 2 diabetes.”

Source: Eli Lilly and Company

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