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.