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Merck, Pfizer: FDA Approves Steglatro And Fixed-dose Combination Steglujan

Merck & Co. Inc. (MRK) and Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 or SGLT2 inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) 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 and 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 (such as anaphylaxis or angioedema).

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.

Diabetes is a chronic, progressive disease affecting approximately 30 million Americans. About one-third of adults with type 2 diabetes in the U.S. are not at their A1C goal.

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