FDA Approves 3 New Drugs for T2D in Adults
The new approvals were based on data from seven Phase 3 studies involving approximately 4800 patients.
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.
Specifically, Steglatro is indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, 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 4800 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 5 mg and 15 mg doses vs 0.2% reduction for placebo (P <.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 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 5 mg and 15 mg strength tablets. Steglujan will be available as 5 mg/100 mg and 15 mg/100 mg strength tablets. Segluromet will be available as 2.5 mg/500 mg, 2.5 mg/1000 mg, 7.5 mg/500 mg, and 7.5 mg/1000 mg strength tablets. Steglatro and Steglujan are expected to be available in January 2018 while Segluromet is expected to be available February 2018.
FDA approves SGLT2 inhibitor STEGLATRO™ (ertugliflozin) and fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) for adults with type 2 diabetes [press release]. Kenilworth, NJ & New York; Merck: December 22, 2017. Accessed January 3, 2018.