The manufacturers of 3 medications containing ertugliflozin, an investigational SGLT2 inhibitor, have applied to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval to market their products for glycemic control in adults with type 2 diabetes.
Merck and Pfizer today announced that the FDA has accepted 3 new drug application, one for monotherapy, one for a fixed-dose combination of ertugliflozin and sitagliptin (Januvia/Merck) and one for the fixed-dose combination of ertugliflozin and metformin.
The action date from the FDA is in December 2017 for all 3.
The EMA has validated for review 3 marketing authorization applications for ertugliglozin monotherapy and the 2 fixed-dose combination products.
The companies said the marketing applications are supported by studies in the VERTIS clinical development program of ertugliflozin, including VERTIS MONO, VERTIS FACTORIAL, and VERTIS SITA2, which were first presented a medical conferences in 2016.
The full VERTIS clinical development program is comprised of 9 phase 3 trials in approximately 12,600 adults with type 2 diabetes.
"The acceptance of the 3 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,” said Sam Engel, MD, associate vice president, Merck clinical research, diabetes and endocrinology. “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.”
At Pfizer, James Rusnak, MD, PhD, 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,”
Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The drug has not been studied in patients with a history of pancreatitis so it is unknown whether it poses a risk to these patients, or a risk of other patients developing pancreatitis. There has been some postmarketing reports of acute pancreatitis, so physicians are cautioned to discontinue the drug if that condition is suspected.
Details are provided in a news release from the two companies.