The U.S. Food and Drug Administration (FDA) has approved Glyxambi® (empagliflozin/linagliptin) tablets that can improve glycemic control in adults with type 2 diabetes.
The medication would be prescribed as an addition to healthy diet and exercise habits in cases where empagliflozin and linagliptin are appropriate treatments, a news release reported. The drug is the first to combine the benefits of the sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in once-daily pill.
"Today's medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control," said Paul Fonteyne, president and CEO, BIPI. "With GLYXAMBI, the dual inhibition of DPP-4 and SGLT2 - two proven targets in the treatment of type 2 diabetes - now provides U.S. 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."
The drug works by increasing hormones that stimulate the pancreas to produce more insulin and causing the liver to reduce its glucose production.
The medical searchers noted GLYXAMBI increases the risk of developing pancreatitis in patients with a history of the condition. It is not recommended for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. The drug should also not be taken by patients with "renal impairment, end-stage renal disease or dialysis; a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity; or history of serious hypersensitivity reaction to empagliflozin," the news release reported.
"Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever," Mike Mason, vice president, U.S., Lilly Diabetes. "The approval of GLYXAMBI gives U.S. 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."
