Updated Nuwiq ® prescribing information includes data on effective bleeding protection through personalized prophylaxis when administered twice a week
LACHEN, Switzerland – (BUSINESS WIRE) – As announced today by Octapharma, the European Medicines Agency has approved an updated technical update (SmPC) for the drug Nuwiq ®, which contains information on personalized prophylaxis in patients with haemophilia A. The updated technical information is available at https://www.ema.europa.eu/en/medicines/human/EPAR/nuwiq
The new information in the updated information is based on data from the NuPreviq study, in which 66 previously treated adult patients switched from a 1 to 3 month standard prophylactic regimen to a 6 month personalized regimen based on their individual pharmacokinetic (PK) characteristics were. Out of the 66 patients reported in the study, 44 changed to a different prophylactic regimen after PK assessment. Of these, 40 completed 6-month prophylaxis according to the assigned dosing and treatment regimen, and 34 patients (85%) were treated twice a week or less. The mean annual bleeding rate among the 40 patients was 1.2 ± 3.9, 90 percent of the patients had no spontaneous bleeding and 83 percent had no bleeding of any kind. The mean SD dose was 52.2 ± 12.2 IU / kg each Injection (99.7 ± 25.6 IU / kg per week) and there were no treatment-related adverse events.
Larisa Belyanskaya, head of Octapharma’s IBU hematology, comments: “At Octapharma we are thrilled with the NuPreviq results and the update of the technical information for Nuwiq ®. The data show that with Nuwiq ® personalized prophylaxis is possible with twice weekly or less frequent administration while maintaining effective bleeding protection. ”
Olaf Walter, board member of Octapharma, adds: "Understanding the benefits of using pharmacokinetic data when developing the treatment regimen will help further personalize care for people with haemophilia A. We are proud to work towards this important goal. ”
Octapharma AG, with its headquarters in Lachen, Switzerland, is one of the world’s largest manufacturers of human protein products. Octapharma has been committed to patient care and medical innovation for over 30 years. Octapharma’s core business is the development, manufacture and marketing of human proteins based on human plasma and human cell lines. Patients from over 100 countries are treated with products in the following areas of application:
- Hematology (coagulation disorders)
- Immunotherapy (immune disorders)
- Intensive care and emergency medicine
Octapharma operates state-of-the-art production facilities in Germany, France, Austria, Sweden and Mexico.
About Hemophilia A
Hemophilia A is an inherited, X-linked disease that is caused by a factor VIII deficiency (FVIII) and, if left untreated, leads to bleeding in muscles and joints and thus to arthropathy and high morbidity. About one in 10,000 men worldwide is affected by the disease. Prophylactic FVIII replacement therapy reduces the frequency of bleeding and the risk of permanent joint damage.
Nuwiq ® (Simoctocog alfa) is a fourth generation recombinant factor VIII protein (rFVIII) that is produced in a human cell line without chemical modification or fusion with another protein. 1 Nuwiq ® is cultivated without additives of human or animal origin or antigenic non-human protein epitopes and has a high affinity for the Willebrand coagulation factor. 1 Treatment with Nuwiq ® has been studied in seven completed clinical studies with 201 previously treated patients (PTPs, 190 people) with severe haemophilia A, including 59 children. 1 Nuwiq ® is approved for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) in all age groups. 2 Nuwiq ® is available in dosage forms with 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU, each as an ampoule with an infusion volume of 2.5 ml, and is supplied with a pre-filled syringe. 2
- Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177 / 2040620719858471.
- Nuwiq ® – specialist information for the drug
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