Novo Nordisk (NVO) said Sunday its phase 3b study found switching to Mim8 from emicizumab without a break was well-tolerated in adults and adolescents with haemophilia A, a genetic bleeding disorder.
No safety concerns were identified. There were also no thromboembolic events, hypersensitivty reactions or treatment-related adverse events leading to discontinuation, the company said.
Meanwhile, thrombin levels increased into the normal range following the switch but remained within safe limits, avoiding any clotting risks, the company said.
The company also said 97% of participants preferred the Mim8 pen injector over their previous injection system, while 98% found it easy to use.
Novo Nordisk said it plans to seek regulatory approval for Mim8 this year and will present additional results from the Frontier program at upcoming conferences.
Shares of Novo Nordisk declined more than 3% in recent Monday premarket activity.
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