Ertugliflozin Undergoing FDA Review

FDA has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose combination of ertugliflozin and sitagliptin, and one for the fixed-dose combination of ertugliflozin and metformin.

These marketing applications to the FDA and EMA are supported by studies in the VERTIS clinical development program of ertugliflozin, including VERTIS MONO, VERTIS FACTORIAL, and VERTIS SITA2. The full VERTIS clinical development program is comprised of nine Phase 3 trials in approximately 12,600 adults with type 2 diabetes.

In a clinical trial conducted last year, it was seen that ertugliflozin provided significant improvements in HbA1c, fasting plasma glucose, and body weight when compared to sitagliptin and placebo. Sitagliptin provided similar A1c reductions and fasting blood glucose reductions, however, it did not provide any effect on blood pressure as opposed to ertugliflozin alone.

Read more