BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - Novo Nordisk announced the European Medicines Agency's CHMP has adopted a positive opinion, recommending approval of Alhemo as the first once-daily subcutaneous prophylactic treatment for people aged 12 years or older living with haemophilia A or B with inhibitors. The CHMP positive opinion is based on data from the phase 3 explorer study.
If approved, Alhemo will be provided in a portable, pre-mixed and prefilled pen. Novo Nordisk expects a final approval by the European Commission within approximately two months.
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