Novo Nordisk (NVO) said Thursday that the US Food and Drug Administration has approved Alhemo (concizumab-mtci) as a once-daily prophylaxis to prevent or reduce the frequency of bleeding in adults and children above 12 years with hemophilia A or B without inhibitors.
The approval is based on the results of a phase 3 trial which showed that Alhemo cut the annualized bleeding rate by 79% in hemophilia B patients and by 86% in hemophilia A patients compared with no prophylaxis, the company said.
The approval offers patients in this population a subcutaneous injection option expanding on the drug's earlier approval in December 2024 for use in patients with hemophilia A or B with inhibitors, Novo Nordisk said.
Shares of Novo Nordisk were up 2% in early Friday trading.
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