FDA approves ertugliflozin for type 2 diabetes

The FDA approved three new medicines containing the SGLT2 inhibitor ertugliflozin with the indication of improving glycemic control in adults with type 2 diabetes, according to the agency’s Center for Drug Evaluation and Research.

The FDA on Wednesday approved Steglatro (oral ertugliflozin) and the fixed-dose combinations Steglujan (ertugliflozin and sitagliptin [Januvia, Merck]) and Segluromet (ertugliflozin and metformin). The three formulations will be made available in early 2018, according to Merck and Pfizer.

The approvals are based on studies in the VERTIS clinical development program of ertugliflozin, including VERTIS MONO, VERTIS Factorial and VERTIS SITA2, results of which were presented in 2016. The full VERTIS clinical development program includes nine phase 3 trials with approximately 12,600 adults with type 2 diabetes.

The FDA accepted New Drug Applications for the therapies in March.

“Merck welcomes the addition of these medicines to our portfolio, demonstrating our continued efforts to help adults living with type 2 diabetes,” Keith Kaufman, MD, vice president of global clinical development and therapeutic area head for diabetes, endocrinology and women’s health, Merck Research Laboratories, told Endocrine Today.

“Pfizer is proud to have discovered the molecule that is now Steglatro, and we are pleased that its development has led to new treatment options for type 2 diabetes patients,” James Rusnak, MD, PhD, senior vice president and chief development officer, internal medicine, Pfizer Global Product Development, told Endocrine Today.

Juan Pablo Frias, MD, president and principal investigator, National Research Institute, Los Angeles, said the approval of ertugliflozin offers clinicians a new therapeutic option that will especially benefit patients with type 2 diabetes and overweight, obesity or hypertension.

“The complementary mechanisms of action of SGLT-2 inhibitors like ertugliflozin and DPP-4 inhibitors like sitagliptin make them an ideal combination,” Frias told Endocrine Today. “Each act on different pathophysiologic defects that contribute to hyperglycemia in type 2 diabetes. Recent diabetes treatment guidelines highlight the importance of considering combination therapy early in the course of treatment for type 2 diabetes. The approval of Steglatro and strong clinical data supporting its use in combination with other agents, provides clinicians additional therapeutic options with which to treat patients and treat them early.”

Segluromet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. Segluromet not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The labeling for Segluromet contains a Boxed Warning for lactic acidosis.

Steglatro is available in 5 mg and 15 mg tablets. Steglujan combines 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin. Segluromet combines 2.5 mg or 7.5 mg of ertugliflozin with 500 mg or 1,000 mg of metformin hydrochloride.