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General Information

Nuwiq Antihemophilic Factor (Recombinant) is an intravenous therapy.The B-domain deleted recombinant Factor VIII (FVIII) is derived from a human cell-line, not chemically modified or fused with another protein.

Nuwiq is specifically indicated for the treatment and prophylaxis of bleeding in pediatric and adult patients with hemophilia A (congenital factor VIII deficiency).

Nuwiq is supplied a solution for intravenous administration. Please see drug label for dosing specifications.

Clinical Results

FDA Approval

The FDA approval of Nuwiq was based on the following trials:

A pharmacokinetic (PK) evaluation in an open-label, multi-center clinical trial of 22 (20 adults, 2 adolescents) previously treated patients. In this study, Nuwiq demonstrated a mean half-life of 17.1 hours using a one-stage clotting assay in adults. Nuwiq was also evaluated in children using a one-stage clotting assay with a mean half-life of 11.9 hours for ages 2 to 5; and a mean half-life of 13.1 hours for ages 6 to 12. These PK results for mean half-life were longer than earlier generations of recombinant FVIII products currently available in the U.S.

Three prospective, open-label clinical studies were conducted in previously treated subjects with severe Hemophilia A. Across all clinical studies, a total of 135 patients with Hemophilia A were treated with Nuwiq, including 74 adults, 3 adolescents between ages 12 and 17, and 58 pediatric patients between ages 2 and 11. These 135 patients were treated with a total of 16,134 infusions over 15,950 exposure days using Nuwiq. In a study of 32 adults, overall prophylactic efficacy of Nuwiq for spontaneous bleeds was rated as excellent or good in 92% of patients. In a study of 59 children, prophylactic efficacy for spontaneous bleeds was rated as excellent or good in 97% of patients. The mean annualized bleeding rates (ABR) for spontaneous bleeds during prophylaxis were approximately 1.5 in children and 1.2 in adults. For Hemophilia A patients receiving Nuwiq prophylaxis compared to on-demand treatment, the ABR was reduced 96% for adults and 93% for children. Treatment of breakthrough bleeds during Nuwiq prophylaxis was rated as excellent or good in 30 of 30 (100%) bleeds in adults and for 89 of 108 (82%) bleeds in children. For on-demand treatment with Nuwiq in 20 adults and 2 adolescents, efficacy for the treatment of bleeds was excellent or good in 931 of 986 (94%) bleeds. Overall efficacy in surgical prophylaxis was rated excellent or good in 32 of 33 (97%) procedures using Nuwiq.