HATTERSHEIM, Germany, July 3, 2020 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options for IDELVION® [albutrepenonacog alfa, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], CSL Behring's novel, long-acting recombinant albumin fusion protein for treating haemophilia B1. The routine prophylaxis dosing regimen has been updated to include new data about the possibility of further extension of the treatment interval up to 21-day dosing for appropriate adult patients. This makes IDELVION® the first and only factor IX therapy that may be used with a 21-day dosing regimen, in accordance with the information contained within the SmPC2.
HATTERSHEIM, Germany, July 3, 2020 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options for IDELVION® [albutrepenonacog alfa, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], CSL Behring's novel, long-acting recombinant albumin fusion protein for treating haemophilia B1. The routine prophylaxis dosing regimen has been updated to include new data about the possibility of further extension of the treatment interval up to 21-day dosing for appropriate adult patients. This makes IDELVION® the first and only factor IX therapy that may be used with a 21-day dosing regimen, in accordance with the information contained within the SmPC2.
Hemophilia B has new treatment