Acquired haemophilia

Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients

Retrieved on: 
Monday, October 19, 2020

Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ, Octapharmas human cell line-derived recombinant factor VIII (FVIII).

Key Points: 
  • Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ, Octapharmas human cell line-derived recombinant factor VIII (FVIII).
  • The updated PI includes immunogenicity data from the NuProtect study in previously untreated patients (PUPs).
  • FVIII inhibitor development is the most serious treatment complication in previously untreated patients (PUPs) with severe haemophilia A.
  • The updated NUWIQ PI includes data from the NuProtect study, which was the largest prospective study of a single FVIII product in true PUPs.