Novo Nordisk Applies for FDA Approval for Mim8

Mim8 (denecimig) is an injection therapy for preventing bleeds in people with hemophilia A with or without inhibitors. Antibody-based, Mim8 is designed to bypass the need for factor VIII products by mimicking the function of factor VIII and stimulating the production of thrombin, an enzyme that helps blood clot. Because Mim8 works without providing an external source of factor VIII, it can be used to prevent bleeds in hemophilia A patients with and without inhibitors. If approved, Mim8 would be sold as a single-use, prefilled disposable pen for subcutaneous injections once every month, once every two weeks, or once every week.

Source: LA Kelley Communications, Inc., Communique, October 2025