A new sodium-glucose co-transporter 2 medication to treat type 2 diabetes is joining the field: the FDA approved ertugliflozin (Steglatro) from Merck and Pfizer as a single therapy and in combination with Merck’s sitagliptin (Januvia), a DPP-4 inhibitor, or with metformin.
The sodium-glucose co-transporter 2 (SGLT2) class of medications to treat type 2 diabetes just got another competitor as the FDA approved ertugliflozin (Steglatro) from Merck and Pfizer. The drug will compete with 3 other SGLT2 inhibitors already on the market: AstraZeneca’s Farxiga, Johnson & Johnson’s Invokana, and Eli Lilly and Boehringer Ingelheim’s Jardiance.
The approval is for Steglatro as a single therapy and in combination with Merck’s sitagliptin (Januvia), a DPP-4 inhibitor, or with metformin. According to the label, Steglatro is recommended with a starting dose of 5 mg once daily, and the dose can be increased to 15 mg once daily in those who need additional glycemic control. The fixed-dose of Steglatro and Januvia will be sold as Steglujan.
In June, Merck and Pfizer released data at the 77th Scientific Sessions of the American Diabetes Association that found Steglatro achieved significant reductions in glycated hemoglobin (A1C). Results from VERTIS MET—Steglatro with metformin—found that patients on the treatment reported A1C reductions of 0.7% for the 5 mg dose and 0.9% for the 15 mg dose after 26 weeks. In VERTIS SITA—Steglatro with Januvia—patients saw A1C drop by 1.6% on the 5 mg dose and 1.7% on the 15 mg dose.
Patients who took Steglatro also experienced reductions in fasting plasma glucose, reductions in systolic and diastolic blood pressure, and weight loss.
“These results, combined with findings from other studies in the VERTIS program, underscore the potential of ertugliflozin as an important therapeutic option for adults with type 2 diabetes to help improve their glycemic control,” James Rusnak, MD, PhD, now the senior vice pesident and chief development officer, Internal Medicine, Pfizer Global Product Development, said in a statement at the time. “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.”
Reuters reported that the companies plan to make the medicines available in early 2018, and that analysts forecast annual sales will exceed $1 billion.