Posted by Michael Wonder on 30 Sep 2025
Novo Nordisk submits biologics license application to FDA for Mim8; an investigational, prophylaxis treatment for people living with haemophilia A with or without inhibitors
29 September 2025 - In haemophilia A, denecimig is designed to help the body form blood clots more effectively and was studied as part of the FRONTIER program across different dosing frequencies, age groups, severities, and with or without inhibitors.
Today, Novo Nordisk announced Mim8 (denecimig) has been submitted for review to the US FDA through a biologics license application, a formal request to evaluate a biologic medicine.
