Merck and Pfizer announced that the Food and Drug Administration (FDA) has approved Steglatro (ertugliflozin) tablets and Steglujan (ertugliflozin and sitagliptin) tablets for use in adults with type 2 diabetes mellitus.
Specifically, Steglatro is indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and Steglujan is indicated as adjunct when treatment with both ertugliflozin and sitagliptin are appropriate. Ertugliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor and sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor.
The new approvals were based on data from seven Phase 3 studies involving approximately 4,800 patients. Steglatro was evaluated 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. The data showed significant A1c reductions when Steglatro was used alone or with sitagliptin.
In VERTIS SITA2, a 26-week, double-blind, placebo-controlled study (n=463), Steglatro was compared to placebo in patients with inadequately controlled type 2 diabetes taking background metformin and sitagliptin. Significant additional A1c reductions on top of metformin plus sitagliptin were seen with 0.7% and 0.8% reductions, respectively, for the 5mg and 15mg doses vs 0.2% reduction for placebo (P<0.001).
The FDA has also approved Segluromet (ertugliflozin and metformin HCl), which is indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are inadequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.
Steglatro will be available as 5mg and 15mg strength tablets. Steglujan will be available as 5mg/100mg and 15mg/100mg strength tablets. Segluromet will be available as 2.5mg/500mg, 2.5mg/1000mg, 7.5mg/500mg, and 7.5mg/1000mg strength tablets. Steglatro and Steglujan are expected to be available in January 2018 while Segluromet is expected to be available February 2018.