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FDA approves Nuwiq for treatment of hemophilia A
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The FDA approved an intravenous antihemophilic factor recombinant product for the treatment of adults and children with hemophilia A who have congenital Factor VIII deficiency, according to a press release from its manufacturer.
The indication allows human coagulation Factor VIII (rDNA), simoctocog alfa (Nuwiq, Octapharma) to be used for on-demand treatment and control of bleeding episodes. The agent also can be used for routine prophylaxis to reduce frequency of bleeding episodes, as well as perioperative management of bleeding.
Nuwiq is the first B-domain–deleted recombinant Factor VIII derived from a human cell line for hemophilia A.
“Octapharma has been committed to the bleeding disorders community for many years and its decade-long drive to find solutions for hemophilia A challenges has never wavered,” Flemming Nielsen, president of Octapharma USA, said in the press release. “Early development strategies were integral in the development of Nuwiq and these initial goals have been realized with the FDA approval.”
Study results showed Nuwiq’s overall prophylactic efficacy for spontaneous bleeds appeared good or excellent in 92% of adults (n = 32) and 97% of children (n = 59). Researchers reported mean annualized bleeding rates for spontaneous bleeds of 1.2 in adults and 1.5 in children.
Adults who received prophylaxis rather than on-demand treatment demonstrated a 96% reduction in annualized bleeding rate, whereas children who received prophylaxis demonstrated a 93% reduction in annualized bleeding rate.
Company officials reported a 0.7% adverse event rate in all clinical studies of Nuwiq. In these studies, which included a combined 135 participants, researchers reported one case each of paresthesia, headache, injection site pain, injection site inflammation, dry mouth, back pain and vertigo.