March 6, 2017
Merck and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development for helping to 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. Furthermore, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products.
Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology, said: “The acceptance of the three applications by both the FDA and EMA represents an important milestone in the progression of our collaboration with Pfizer on ertugliflozin, and reflects Merck’s commitment to advancing new treatment options for people with type 2 diabetes around the world. If approved, we believe ertugliflozin will be an important option for many patients and a welcome addition to our already strong type 2 diabetes portfolio, with our DPP-4 inhibitor JANUVIA as the foundation.”
James Rusnak, M.D., Ph.D., chief development officer, cardiovascular and metabolic diseases, Pfizer Global Product Development, commented: “Because type 2 diabetes is a progressive disease, patients may need multiple treatment options to help them manage their condition. That is why we are proud of the comprehensive VERTIS clinical development program, and we look forward to working closely with the FDA and EMA in an effort to bring these three additional treatment options to adults with type 2 diabetes.”
U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizerlast edit: 2017-03-13T17:19:44+00:00da