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FDA, EMA accept three new drug applications for ertugliflozin therapies
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The FDA has accepted three New Drug Applications for medicines containing ertugliflozin, an investigational SGLT2 inhibitor, Merck and Pfizer announced in a press release.
The three drugs are intended to improve glycemic control in adults with type 2 diabetes. One application is for ertugliflozin as monotherapy, one is for the fixed-dose combination of ertugliflozin and sitagliptin (Januvia; Merck), and one is for the fixed-dose combination of ertugliflozin and metformin.
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, results of which were presented in 2016. The full VERTIS clinical development program comprises nine phase 3 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,” Sam Engel, MD, associate vice president, Merck clinical research, diabetes and endocrinology, said in a statement. “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-IV 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,” James Rusnak, MD, PhD, chief development officer, cardiovascular and metabolic diseases, Pfizer Global Product Development, said in the statement. “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.”