Novo Nordisk has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for Mim8 (denecimig), an investigational bispecific antibody therapy. The antibody promotes coagulation by binding two key proteins (factor IXa and factor X), essentially mimicking the function of the missing factor VIII in the clotting cascade.
Denecimig can be administered subcutaneously via a single-use, prefilled disposable pen injector device. According to the company’s recent press release, product options for dosing would include – once every month, once every two weeks, or once per week - for people living with hemophilia A with or without inhibitors.
Novo’s BLA submission was based on results of the FRONTIER clinical study program, a series of clinical trials designed to establish the efficacy and safety of denecimig as a prophylactic therapy to prevent or reduce the frequency of bleeding episodes in people with hemophilia A, with or without inhibitors.
"It is important that we continue to drive scientific advances in hemophilia A, and the FRONTIER program supports the potential of denecimig as a prophylaxis bleed treatment option for a range of patients across dosing frequencies, age groups, and condition severity, regardless of inhibitor status," said Anna Windle, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. "A cornerstone of hemophilia treatment is to help prevent bleeding episodes, and this submission is another step forward in our long-standing mission to help improve care”, added Windle who went on to say, “if approved, denecimig's single-dose prefilled injector pen and flexible dosing schedule may better fit into the lives of people living with this challenging condition."
Source: PR Newswire, September 29, 2025
