Merck and Pfizer file Three Ertugliflozin Applications in Type 2 Diabetes
The FDA and EMA have accepted marketing applications for a Merck and Pfizer collaboration on three treatments containing ertugliflozin, for improving glycemic control in adults with type 2 diabetes.
The applications include: a monotherapy, a fixed-dose combination of ertugliflozin and Januvia (sitagliptin), and a fixed-dose combination of ertugliflozin and metformin.
The clinical development program involved nine Phase III trials in approximately 12,600 adults with type 2 diabetes. The FDA has set a PDUFA action date for December.