Update van de samenvatting van de productkenmerken voor Nuwiq® bevat gegevens over effectieve bloedingsbescherming met tweemaal per week doseren met gepersonaliseerde profylaxe
LACHEN, Zwitserland (BUSINESS WIRE) – Octapharma kondigde vandaag aan dat het Europees Geneesmiddelenbureau een bijgewerkte samenvatting van de productkenmerken (SmPC) voor Nuwiq® heeft geautoriseerd, die informatie bevat over gepersonaliseerde profylaxe bij patiënten met hemofilie A. De bijgewerkte SmPC kan worden geraadpleegd op https://www.ema.europa.eu/en/medicines/human/EPAR/nuwiq
De nieuwe informatie in de bijgewerkte SmPC is gebaseerd op gegevens uit de NuPreviq-studie, waarbij 66 eerder behandelde volwassen patiënten werden overgeschakeld van een standaard profylaxe-regime van 1 tot 3 maanden naar een gepersonaliseerd schema van 6 maanden op basis van hun individuele farmacokinetische (PK) kenmerken. Van de 66 patiënten die in de studie werden gerapporteerd, schakelden 44 patiënten over naar een ander profylaxe-regime na PK-beoordeling. Veertig van hen voltooiden de 6 maanden profylaxe volgens het toegewezen doserings- en behandelingsschema en 34 patiënten (85%) werden tweemaal per week of zelfs minder vaak behandeld. Het gemiddelde jaarlijkse bloedingspercentage bij de 40 patiënten was 1,2 ± 3,9, 90% van de patiënten had geen spontane bloedingen en 83% had geen enkele bloeding van welke aard dan ook. De gemiddelde dosis ± SD was 52,2 ± 12,2 IE/kg per injectie (99,7 ± 25,6 IE/kg per week) en er waren geen behandelingsgerelateerde bijwerkingen.
Update of Summary of Product Characteristics for Nuwiq® includes data on effective bleed protection with twice-weekly dosing with personalised prophylaxis
LACHEN, Switzerland–(BUSINESS WIRE)– Octapharma announced today that the European Medicines Agency has authorised an updated Summary of Product Characteristics (SmPC) for Nuwiq® that includes information on personalised prophylaxis in patients with haemophilia A. The updated SmPC can be accessed at https://www.ema.europa.eu/en/medicines/human/EPAR/nuwiq
The new information in the updated SmPC is based on data from the NuPreviq study in which 66 previously treated adult patients were switched from a 1 to 3-month standard prophylaxis regimen to a 6-month personalised regimen based on their individual pharmacokinetic (PK) characteristics. Of the 66 patients reported in the study, 44 patients switched to a different prophylaxis regimen after PK assessment. Of these, 40 completed the 6 months of prophylaxis according to the assigned dosing and treatment scheme, and 34 patients (85%) were treated twice weekly or even less frequently. The mean annualised bleeding rate among the 40 patients was 1.2 ± 3.9, 90% of patients experienced no spontaneous bleeds, and 83% had no bleeds of any type. The mean ± SD dose was 52.2 ± 12.2 IU/kg per injection (99.7 ± 25.6 IU/kg per week), and there were no treatment-related adverse events.
Larisa Belyanskaya, Head of Octapharma’s IBU Haematology commented “we at Octapharma are delighted with the NuPreviq results and the update to the Nuwiq® Summary of Product Characteristics. The data show that personalised prophylaxis with Nuwiq® may enable twice weekly or less frequent dosing while maintaining effective bleed protection”.
Olaf Walter, Board Member at Octapharma, added “Understanding the benefits of using pharmacokinetic data to guide treatment will help further personalise the care of people with haemophilia A and we are proud to be driving efforts to achieve this important goal”.
About Octapharma
Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest manufacturers of human protein products in the world. For over 30 years, Octapharma has been committed to patient care and medical innovation. Its core business is the development, production and sale of human proteins from human plasma and human cell lines. Patients in over 100 countries are treated with Octapharma products in the following therapeutic areas:
- Haematology (coagulation disorders)
- Immunotherapy (immune disorders)
- Critical Care
Octapharma owns state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.
About Haemophilia A
Haemophilia A is an X-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, leads 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 protein.1 Nuwiq® is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor.1 Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 previously treated patients (PTPs; 190 individuals) with severe haemophilia A, including 59 children.1 Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) across all age groups.2 Nuwiq® is available in 250 IU, 500 IU, 1000 IU, 2000 IU , 2500 IU, 3000 IU and 4000 IU presentations with all vial strengths in a 2.5 mL infusion volume and supplied with a pre-filled syringe.2
- Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.
- Nuwiq® Summary of Product Characteristics.
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Contacts
Octapharma AG
International Business Unit – Haematology
Olaf Walter
Olaf.Walter@octapharma.com
Larisa Belyanskaya
Larisa.Belyanskaya@octapharma.com
Tel: +41 55 4512121
Ivana Spotakova
Communications Manager
ivana.spotakova@octapharma.com
Tel.: +41793474607