FDA Approves Pfizer and Merck's Ertugliflozin for Type 2 Diabetes
Ertugliflozin, an SGLT2 inhibitor from Merck & Co. and Pfizer, was approved as both a monotherapy and fixed-dose combination therapy.
The US Food and Drug Administration (FDA) has approved ertugliflozin (Steglatro) for the treatment of glycemic control in patients with type 2 diabetes (T2D).
Ertugliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor from Merck & Co. and Pfizer, was approved as both a single therapy and fixed-dose combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin (Januvia) or common first-line therapy metformin. The combination therapies will carry the brand names Steglujan and Segluromet, respectively.
Merck and Pfizer previously announced successfully-met endpoints for the combination therapies in 2 phase 3 trials (VERTIS MET, VERTIS SITA) in June.
VERTIS MET, a 26-week study which evaluated the safety and efficacy of 5 mg and 15 mg ertugliflozin with metformin, compared the combination therapy at both doses, with placebo and metformin in adult patients with uncontrolled T2D currently taking metformin monotherapy.
The patients taking both doses of ertugliflozin-combination reported greater reductions in average blood-glucose (A1C) over a multi-month span (0.7% and 0.9% for 5 mg and 15 mg, respectively) versus placebo (0.0%, P < 0.001). Ertugliflozin also significantly reduced patients’ fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and diastolic blood pressure (DBP), versus placebo.
In VERTIS SITA, 5 mg and 15 mg ertugliflozin were tested in combination with sitagliptin 100 mg verus placebo with sitagliptin. Ertugliflozin patients reported greater reductions in A1C for both 5 mg (1.6%) and 15 mg (1.7%) versus placebo (0.4%, P < 0.001). The combination doses also significantly reduced FPG, body weight, and SBP in its patients versus placebo.
At the time of the announced study results, James Rusnak, MD, PhD, senior vice president and chief development officer, Internal Medicine, Pfizer Global Product Development, said the results “underscore the potential of ertugliflozin as an important therapeutic option” for adults with T2D.
“As the global burden of diabetes continues to rise, we are committed to meeting patients’ needs with additional treatment options to help manage their condition,” Rusnak said.
The therapies are anticipated to be made available in early 2018.
