Merck, known as MSD outside the U.S. and Canada, and Pfizer, have announced that the 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 (PDUFA) action date from the FDA is in December 2017 for the three NDAs.
Additionally, the EMA has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products.
These marketing applications to the FDA and EMA are supported by studies in the VERTIS clinical development program of ertugliflozin, including VERTIS MONO, VERTIS FACTORIAL and VERTIS SITA2, which were first presented at medical congresses in 2016. The full VERTIS clinical development program is comprised of nine phase III trials in approximately 12,600 adults with type 2 diabetes.
“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,” said Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology. “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.”
“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,” said James Rusnak, M.D., Ph.D., chief development officer, cardiovascular and metabolic diseases, Pfizer Global Product Development.