Merck announces FDA approval for STEGLATRO, STEGLUJAN
Merck (MRK) and Pfizer (PFE) announced that the U.S. Food and Drug Administration has approved STEGLATROTM tablets, an oral sodium-glucose cotransporter 2 inhibitor, and the fixed-dose combination STEGLUJAN tablets.
STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.
STEGLATRO and STEGLUJAN are not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
STEGLUJAN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN.
STEGLATRO and STEGLUJAN are contraindicated in patients with severe renal impairment, end-stage renal disease or on dialysis, or with a history of a serious hypersensitivity reaction to ertugliflozin.
STEGLUJAN is also contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin.
These FDA approvals are supported by seven Phase 3 studies of approximately 4,800 patients.
STEGLATRO was studied as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type 2 diabetes and moderate renal impairment.
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