Novo Nordisk (NVO) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended expanding the use of Alhemo to more haemophilia patients.
The update would allow Alhemo to treat adults and children aged 12 and up with severe haemophilia A or moderate to severe haemophilia B without inhibitors.
The recommendation is based on a phase 3 trial that showed Alhemo significantly reduced spontaneous and traumatic bleeding compared with no prophylaxis.
The treatment also showed a favorable safety profile when delivered via a pen-injector device.
Novo Nordisk said it expects the European Commission to approve the label update within about two months.
The company's shares were up 1% in recent trading.
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