- Novo Nordisk submitted a BLA for Mim8 to the FDA on Sept. 29, 2025.
- Mim8 is a bispecific antibody designed for hemophilia A treatment.
- Dosing options include once a month, every two weeks, or weekly.
- The FRONTIER program supports Mim8's efficacy and safety profile.
FDA Submission
Novo Nordisk has submitted a Biologics License Application (BLA) to the FDA for Mim8, an investigational treatment for hemophilia A. The submission took place on September 29, 2025.
About Mim8
Mim8, also known as denecimig, is a next-generation bispecific antibody designed to mimic Factor VIIIa. It aims to prevent or reduce bleeding episodes in patients with hemophilia A, with or without inhibitors.
Dosing Flexibility
If approved, Mim8 will offer flexible dosing options, including once a month, every two weeks, or weekly, using a pre-filled, single-use pen injector.
FRONTIER Program
The FDA submission is based on the FRONTIER study program, which evaluated Mim8's efficacy and safety across various dosing frequencies, age groups, and severities of hemophilia A. The program includes studies FRONTIER1-5, focusing on both pediatric and adult populations.
Hemophilia A Overview
Hemophilia A is a rare inherited disorder affecting blood clotting, caused by a deficiency in Factor VIII. It affects approximately 836,000 people worldwide, with 80-85% of cases being hemophilia A. Around 30% of patients may develop inhibitors, complicating treatment.
