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.