On Friday, Novo Nordisk A/S NVO introduced interim outcomes from the part 3 FRONTIER3 trial of 70 kids (aged 1-11 years outdated) with hemophilia A with and with out inhibitors.
The trial initially assessed once-weekly prophylaxis therapy (common therapy to stop extended and spontaneous bleeding) with investigational Mim8 earlier than giving individuals the choice to vary to once-monthly dosing after 26 weeks.
Partially one of many FRONTIER3 research, individuals acquired once-weekly doses of Mim8 for 26 weeks.
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Partially two, individuals may proceed with once-weekly dosing or transfer to once-monthly dosing for the remaining 26 weeks.
- The interim evaluation stories outcomes after half one of many research, with some preliminary information shared from half two, which continued following this evaluation.
- For half one of many research in kids on once-weekly prophylaxis, the estimated imply (common) annualized bleeding charge (ABR) for handled bleeds was 0.53.
The median ABR was zero; 74.3% of individuals had zero handled bleeds.
All kids with hemophilia A with inhibitors (n=14) reported zero handled bleeds. After finishing the preliminary 26 weeks of the research, 45% of individuals moved to once-monthly Mim8, and the remaining (55%) remained on the once-weekly dose.
The information confirmed that Mim8 was well-tolerated and efficacious.
Novo Nordisk expects Mim8 regulatory submission throughout 2025. Information from the continuing part 3 FRONTIER program can be disclosed at upcoming congresses and in publications in 2025 and 2026.
In Might 2024, Novo Nordisk launched headline outcomes from the FRONTIER 2 Section 3a trial of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation issue prophylaxis therapy in hemophilia A sufferers 12 years or older with or with out inhibitors.
The trial achieved its co-primary endpoints by demonstrating a statistically vital and superior discount of handled bleeding episodes with each once-weekly and once-monthly Mim8 versus no prophylaxis therapy and prior coagulation issue prophylaxis therapy.
In June 2024, Novo Nordisk acquired the Hemophilia A program and rights to 2seventy Bio Inc. TSVT in vivo gene modifying know-how outdoors of oncology and gene modifying for autologous or allogeneic cell therapies of immune cells for autoimmune illness.
Worth Motion: NVO inventory is down 2.33% at $89.20 throughout the premarket session on final examine Friday.
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