Regulators on both sides of the Atlantic are reviewing three new submissions for medicines containing ertugliflozin, an investigational SGLT2 inhibitor being developed by Merck and Pfizer to help improve glycaemic control in adults with type II diabetes.
One application is seeking approval for the drug as a monotherapy, one for a fixed-dose combination of ertugliflozin and Januvia (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin.
“If approved, we believe ertugliflozin will be an important option for many patients and a welcome addition to our already strong type II diabetes portfolio, with our DPP-4 inhibitor Januvia as the foundation,” Sam Engel, associate vice president, Merck clinical research, diabetes and endocrinology.
A decision by US Food and Drug Adminstration is expected in December this year.
Merck and Pfizer signed an agreement to co-develop and co-commercialise the latter’s drug in 2013.