CHMP recommendation for Nuwiq for treatment of Haemophilia - Octapharma AG
Octapharma confirmed that the European Medicines Agency (EMA) has adopted a positive opinion towards human cell line recombinant human FVIII, Nuwiq, recommending the granting of a marketing authorisation for the medicinal product for treatment and prophylaxis of bleeding (also during and after surgery) in paediatric and adult patients with Haemophilia A.
Nuwiq is the first new generation FVIII replacement protein, derived from a human cell line awaiting marketing authorisation in Europe. Nuwiq is produced without animal derived products, and devoid of non human epitopes thought to underlie autoimmune reaction. Inhibitor antibodies to replacement FVIII typically neutralise the beneficial effect of the protein, and represent the major challenge in today's management of Haemophilia.
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