Nuwiq®

Human Coagulation Factor VIII (rDNA) (simoctocog alfa)

Human coagulation factor VIII produced in a human cell line by recombinant DNA technology. No animal or human derived materials are added during the manufacturing process or to the final medicinal product.

 
Indication

Nuwiq® is indicated for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) of all age groups.

 
Presentation

Supplied as powder and solvent for solution for injection, with all vial strengths in a 2.5 mL infusion volume and supplied with a pre-filled syringe. Available in vials of: 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU. 

Key features of Nuwiq® 

Convenient twice-weekly dosing to effectively prevent bleeds in patients on personalised prophylaxis1:
  • 83% of patients free from spontaneous bleeds;
  • 57% of patients treated twice-weekly or less;
  • 0 inhibitors or severe treatment related adverse events.
In 66 adult patients with haemophilia A on personalised prophylaxis with Nuwiq®1
 
Favourable rate of inhibitors in previously untreated patients (PUPs) demonstrated in NuProtect, the largest prospective study in true PUPs with a single FVIII product2:
  • 17.6% cumulative incidence of high-titre inhibitors;
  • 27.9% cumulative incidence of all inhibitors;
  • No inhibitors in patients with non-null F8 mutations.
In 105 PUPs in the NuProtect Study2.
 
Zero inhibitors in over 190 previously treated patients switching to Nuwiq®  in clinical trials3
 
References

1. Lissitchkov T et al. Haemophilia 2017; 23:697-704.
2. Liesner R et al. Abstract accepted for presentation at ASH 2019, Orlando, US.  
3. Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.

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