FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Steglatro (ertugliflozin)


Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Additionally, 2 combination products were also approved, Segluromet (ertugliflozin/metformin) and Steglujan (ertugliflozin/sitagliptin).


Inhibition of selective sodium-glucose transporter-2 (SGLT2) lowers the renal glucose threshold. Lowering the renal glucose threshold results in increased urinary glucose excretion.


5 mg PO once daily in the morning. If starting dose tolerated and additional glycemic control is needed, increase dose to maximum of 15 mg once daily.


Approval was based on the VERTIS clinical development program of ertugliflozin, comprising 9 phase 3 clinical trials in approximately 12,600 adults with T2DM. Results showed statistically significant improvements in HbA1c, fasting plasma glucose, body weight, and systolic and diastolic blood pressures.


Terra SG, et al. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017 May;19(5):721-28.

Rosenstock J, et al. Effect of ertugliflozin on glucose control, body weight, blood pressure and bone density in type 2 diabetes mellitus inadequately controlled on metformin monotherapy (VERTIS MET). Diabetes Obes Metab. 2017 Aug 31.

Dagogo-Jack S, et al. Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: The VERTIS SITA2 placebo-controlled randomized study. Diabetes Obes Metab. 2017 Sep 17.


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