Octapharma Announces FDA Approval of Updated Nuwiq® Prescribing Information to Include Immunogenicity Data in Previously Untreated Patients
Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ®, Octapharma’s human cell line-derived recombinant factor VIII (FVIII). NUWIQ ® is approved for the prevention and treatment of bleeding in people with haemophilia A. 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 development of inhibitors against exogenous FVIII can reduce the effectiveness of treatment and negatively impact a patient’s long-term joint health and quality of life. Minimising the risk of inhibitor development is therefore a key consideration in treatment decisions for PUPs.
The updated NUWIQ® PI includes data from the NuProtect study, which was the largest prospective study of a single FVIII product in true PUPs. Patients received NUWIQ® for prophylaxis or on-demand treatment and were followed for 100 exposure days or 5 years. Of the 105 PUPs assessed for inhibitor development, 17 (16.2%) developed high-titre inhibitors and 11 (10.5%) developed low-titre inhibitors, 5 of whom had transient inhibitors. Of the 28 patients who developed an inhibitor, 25 did so within 20 days of treatment exposure and no patients developed inhibitors after 34 exposure days.
“Minimising inhibitor risk is of huge importance for haemophilia A patients at the start of their treatment journey,” added Olaf Walter, Board Member of Octapharma. “This update reflects our commitment at Octapharma to supporting patients at every stage of this journey and provide treatment options that can improve patients’ lives.”
Read the statement in its entirety here (via Business Wire).
Source: Hemophilia Federation of America