(CercleFinance.com) – Novo Nordisk today announced topline results from a pivotal phase 3a trial investigating the efficacy and safety of Mim8 compared to no prophylaxis and compared to prior prophylactic treatment in people aged 12 years or older with hemophilia A with or without inhibitors.
The trial met its co-primary endpoints by demonstrating a statistically significant and greater reduction in bleeding episodes treated with Mim8 administered once weekly and once monthly compared to no prophylactic treatment and prior prophylactic treatment with clotting factor.
In the trial, Mim8 appeared to have a safe and well-tolerated profile, consistent with previous trials. No deaths or thromboembolic events were reported during the trial, the laboratory emphasizes.
“The data demonstrate the ability of Mim8 to effectively and safely prevent bleeding episodes in people with hemophilia A, regardless of their dosing frequency,” said Martin Holst Lange, executive vice president of development at Novo Nordisk.
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