FDA, EMA agree to review three Pfizer and Merck drugs for type 2 diabetics
Ertugliflozin is “an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes,” Pfizer said in a press release.
One drug is for monotherapy, one is for a fixed-dose combination of ertugliflozin and JANUVIA – another diabetes medication – and one is for a fixed-dose combination of ertugliflozin and metformin, according to Pfizer.
The European Medicines Agency (EMA) has also agreed to review three Marketing Authorization Applications (MAAs) for the drugs.
“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 of clinical research, diabetes and endocrinology at Merck, said in the release. “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.”
The applications are based on studies in a clinical development program made up of nine Phase 3 trials involving approximately 12,600 adults with type 2 diabetes.
“Because type 2 diabetes is a progressive disease, patients may need multiple treatment options to help them manage their condition,” Dr. James Rusnak, chief development officer of cardiovascular and metabolic diseases for Pfizer Global Product Development, said in the release. “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.”
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