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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Steglatro (ertugliflozin)

Indication:

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).

Mechanism:

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

Dosage:

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:

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.

References:

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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