Posted by Michael Wonder on 06 Mar 2017
Merck and Pfizer announce U.S. FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes
6 March 2017 - Investigational SGLT2 Inhibitor submitted as monotherapy and in fixed-dose combinations with Januvia (sitagliptin) or metformin.
Merck and Pfizer today announced that the U.S. 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 Januvia (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin. The Prescription Drug User Fee Act action date from the FDA is in December 2017 for the three NDAs.
Additionally, the EMA has validated for review three marketing authorisation applications for ertugliflozin monotherapy and the two fixed-dose combination products.
