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 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”.