Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Er

Pfizer press release ------ Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:FE), today 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 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 European Medicines Agency (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 3 trials in approximately 12,600 adults with type 2 diabetes. To learn more click on the picture below to read the release.