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Novo Nordisk reports positive results from Phase IIIa trial of haemophilia A drug

 Novo Nordisk has shared headline results from FRONTIER II, a Phase IIIa trial assessing subcutaneous Mim8 for haemophilia A treatment.

The 26-week trial involved 254 participants aged 12 and above, comparing once-weekly and once-monthly Mim8 doses against no prophylaxis and prior coagulation factor prophylaxis treatment.

 Both Mim8 doses significantly reduced treated bleeding episodes compared to the control groups, meeting co-primary endpoints.

Patients without prior prophylaxis experienced 97% and 99% reductions with once-weekly and once-monthly Mim8, respectively, with a majority (86% weekly, 95% monthly) reporting no treated bleeds.

For patients previously on prophylaxis, once-weekly and once-monthly Mim8 doses showed 48% and 43% reductions in treated bleeds, respectively.

Mim8 was well-tolerated, with no deaths or thromboembolic events. Novo Nordisk aims for regulatory approval by year-end after consultations with regulatory authorities.