Merck & Co. Inc. (NYSE: MRK) and Pfizer Inc. (NYSE: PFE) each saw their shares sink early on Monday after they gave an update on their type 2 diabetes treatment. The companies announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin.
The Prescription Drug User Fee Act (PDUFA) action date from the FDA is December 2017 for the three NDAs. At the same time, 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 roughly 12,600 adults with type 2 diabetes.
Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology, commented:
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, added:
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.
Shares of Merck were trading down 0.7% at $66.14, within a 52-week trading range of $51.33 to $66.80 and with a consensus analyst price target of $68.65.
Pfizer shares were down 0.7% at $34.29. The consensus price target is $37.95, and the 52-week range is $28.74 to $37.39.