Novo Nordisk today announced top-line results from a pivotal Phase 3a trial investigating the efficacy and safety of Mim8 versus no prophylaxis and versus prior prophylaxis in people aged 12 or older with hemophilia A with or without inhibitors.

The trial met its co-primary endpoints by demonstrating a statistically significant and superior reduction in bleeding episodes treated with Mim8 administered once weekly and once monthly compared to no prophylaxis and prior clotting factor prophylaxis.

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 company points out.

'The data demonstrate Mim8's ability to effectively and safely prevent bleeding episodes in people with hemophilia A, regardless of their frequency of administration,' said Martin Holst Lange, Executive Vice President Development at Novo Nordisk.

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