FDA approves Octapharma's Nuwiq as hemophilia A treatment

The US Food and Drug Administration has approved independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa), antihemophilic Factor (recombinant), an intravenous therapy for adults and children living with hemophilia A.

The Nuwiq approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding, and follows similar market clearance by the European Commission last year. It has also been approved in Australia, Canada and Argentina.

Nuwiq is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of patients with hemophilia A, congenital FVIII deficiency, the company noted.