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Glyxambi approved for glycemic control
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Glyxambi has been approved by the FDA as an add-on to diet and exercise to help improve glycemic control in certain adults with type 2 diabetes, according to a press release from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company.
Glyxambi (empagliflozin/linaglipton, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) is the first diabetes treatment in the United States that combines the actions of a sodium glucose cotransporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a tablet taken once a day. Empagliflozin (10 mg or 25 mg) is combined with linagliptin (5 mg) to make up the drug.
“Today’s medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control,” Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, Inc., said in a press release. “With Glyxambi, the dual inhibition 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 3 trial results showed Glyxambi provided significantly greater reductions in blood glucose levels compared with either empagliflozin or linagliption alone.”
Patients with severe renal impairment, end-stage renal disease or dialysis, a history of hypersensitivity reaction to linagliptin or history of hypersensitivity to empagliflozin should not take Glyxambi. Further, Glyxambi is not a recommended treatment for people with type 1 diabetes or for treatment of diabetic ketoacidosis. Acute pancreatitis has been reported in patients taking linagliptin and patients are urged to watch for potential signs and symptoms of pancreatitis when taking Glyxambi.
“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 of Eli Lilly and Company, said in the release. “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.”