Octapharma kondigt FDA-goedkeuring aan van bijgewerkte NUWIQ®-voorschrijfinformatie om immunogeniciteit gegevens op te nemen bij previously untreated patients (PUP’s)
LACHEN, Zwitserland– (BUSINESS WIRE) – Octapharma is verheugd aan te kondigen dat de Amerikaanse Food en Drug Administration (FDA) een bijgewerkte Prescribing Information (PI) heeft goedgekeurd voor NUWIQ® Octapharma’s menselijke cellijn-afgeleide recombinant factor VIII (FVIII). NUWIQ® is goedgekeurd voor de preventie en behandeling van bloedingen bij mensen met hemofilie A. De bijgewerkte PI bevat immunogeniciteit gegevens van de NuProtect-studie bij previously untreated patients (PUP’s).
De ontwikkeling van FVIII-remmers is de meest ernstige behandelingscomplicatie bijpreviously untreated patientsPUP’s) met ernstige hemofilie A. De ontwikkeling van remmers tegen exogene FVIII kan de effectiviteit van de behandeling verminderen en een negatieve invloed hebben op de gewrichtsgezondheid en kwaliteit van leven van een patiënt op de lange termijn. Het minimaliseren van het risico op de ontwikkeling van remmers is daarom een belangrijke overweging bij behandelbeslissingen voor PUP’s.
Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients
LACHEN, Switzerland–(BUSINESS WIRE)– 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.”
About Haemophilia A
Haemophilia A is an X-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, may lead to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. The disorder affects around one in every 10,000 males worldwide. Prophylaxis with replacement FVIII therapy reduces the number of bleeding episodes and the risk of permanent joint damage.
About Nuwiq®
Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein1. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor1. Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 previously treated patients (190 individuals) with severe haemophilia A, including 59 children1. Nuwiq® is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations, all with a 2.5 mL infusion volume2. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups2.
1. Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.
2. Nuwiq® Summary of Product Characteristics.
About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US.
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Contacts
Macarena Guillamón
corporatecommunications@octapharma.com
+41 (0)55 451 21 21