Ertugliflozin approved as adjunct treatment for type 2 diabetes
As an adjunct to diet and exercise, the drug was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin.
The FDA has approved ertugliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, as an adjunct to diet and exercise for adult patients with type 2 diabetes, as of Dec. 19, 2017.
Ertugliflozin was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin. It will be marketed under the brand names Steglatro, Segluromet, and Steglujan, respectively. The most common adverse reaction is female genital mycotic infections. The FDA is requiring the manufacturer to conduct a randomized, double-blind, placebo-controlled postmarketing trial to examine the effect of the drug on incidence of major cardiovascular events (MACEs) in patients with type 2 diabetes mellitus.
More information about the approval is available online.