Merck & Co., Pfizer's SGLT2 inhibitor Steglatro receives positive opinion from EMA panel

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended approval of Merck & Co. and Pfizer's oral SGLT2 inhibitor Steglatro (ertugliflozin) for the treatment of adults with type 2 diabetes. The CHMP also backed clearance of a fixed-dose combination of ertugliflozin and metformin, which will be marketed under the name Segluromet, as well as a fixed-dose combination of ertugliflozin and Merck's DPP-4 inhibitor Januvia (sitagliptin), which will be sold under the name Steglujan. 

The agency noted that Steglatro is indicated both as monotherapy when metformin is inappropriate and in combination with other diabetes treatments. 

FirstWord reports in this therapy area - KOL Insight Type 2 Diabetes Mellitus: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

Clinical data from the VERTIS programme released in 2016 revealed that Steglatro significantly reduced A1C levels as monotherapy versus placebo, as well as when co-administered with Januvia compared to either drug alone. Further, additional VERTIS programme findings unveiled last year demonstrated that the therapy significantly lowered blood glucose levels when added to metformin in adults with type 2 diabetes uncontrolled on metformin monotherapy, while patients taking the drug in combination with Januvia also achieved significantly greater reductions in A1C versus placebo.

The FDA approved Steglatro, as well as the Segluromet and Steglujan fixed-dose combinations, last month. Merck and Pfizer jointly developed the therapy under the terms of a 2013 partnership

To read more Top Story articles, click here.