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The U.S. Food and Drug Administration (FDA) on Friday approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) tablets.
In 2013, Merck, known as MSD outside the United States and Canada, and Pfizer Inc. announced that they entered into a worldwide collaboration, except Japan, for the co-development and co-promotion of ertugliflozin.
The Merck sales force will exclusively promote Steglatro and the two fixed-dose combination products in the United States. Merck and Pfizer will share potential revenues and certain costs on a 60/40 percent basis, respectively, and Pfizer may be entitled to additional milestone payments.
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 (such as anaphylaxis or angioedema).
In addition to Steglatro and Steglujan (ertugliflozin and sitagliptin), the only fixed-dose combination of an SGLT2 inhibitor and the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin, the FDA also approved the fixed-dose combination Segluromet (ertugliflozin and metformin hydrochloride).
Segluromet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. It is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
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 (90 to 95 percent have type 2 diabetes). About one-third of adults with type 2 diabetes in the U.S. are not at their A1C goal.
Steglatro is available in 5 mg and 15 mg tablets. Steglujan combines 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin. Segluromet combines 2.5 mg or 7.5 mg of ertugliflozin with 500 mg or 1,000 mg of metformin hydrochloride.
This material was prepared specially for the WORLD HEALTH NEWS project by journalist John Bates.
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