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news.Octapharma's Nuwiq has received approval from Health Canada for treatment and prophylaxis of bleeding in patients of all ages suffering with hemophilia A (congenital factor VIII deficiency).
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A new recombinant FVIII, Nuwiq is produced in a human cell line cultured without additives of human or animal origin or any exposure to human blood or plasma, making it inherently free from blood-borne pathogens.
Nuwiq is devoid of antigenic non-human protein epitopes, similar to FVIII produced in healthy humans.
Currently, Nuwiq is under review by regulatory authorities in the US, while it is approved in the EU and Australia with further worldwide submissions planned.
McMaster Children’s Hospital professor Pediatrics and director of the Hemophilia Program Dr Anthony Chan said: "The way Nuwiq is produced is exciting as it allows the molecule to closely resemble the naturally occurring FVIII.
"Health Canada’s approval of Nuwiq® provides patients with hemophilia A a new recombinant product option that will allow further customisation of hemophilia treatment on an individual basis."
The company said that benefit of Nuwiq in terms of prevention and treatment of bleedings and haemostatic efficacy for surgical procedures was evaluated in three pivotal trials.