FDA to review type 2 diabetes drugs from Merck and Pfizer

Merck and Pfizer Inc. recently announced the acceptance for review of three New Drug Applications (NDA) by the U.S. Food and Drug Administration.
The NDAs are for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development that aims to improve glycemic control in adults with type 2 diabetes. The first NDA is to be used for monotherapy, while the second is for the fixed-dose combination of ertugliflozin and JANUVIA (sitagliptin), and the third is for the fixed-dose combination of ertugliflozin and metformin.
“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,” Dr. Sam Engel, associate vice president for 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-4 inhibitor JANUVIA as the foundation.”
Dr. James Rusnak, chief development officer for cardiovascular and metabolic disease at Pfizer Global Product Development, noted that the progressive nature of type 2 diabetes means that many patients need multiple treatment options for managing their condition. For this reason, Pfizer supports a comprehensive clinical development program.