Idelvion becomes first and only Factor IX therapy with 21-day prophylactic dosing for treating haemophilia B. CSL Behring.

CSL Behring announced 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 B.

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.

“This longer treatment interval provides the opportunity for additional dosing options for patients and healthcare professionals, thus improving further tailored treatment with Idelvion.” said Dr Giancarlo Castaman, Director of the Centre for Bleeding Disorders and Coagulation in Careggi Hospital, Florence, Italy.Idelvion, the most prescribed prophylactic treatment for Haemophilia B globally , is the first and only factor IX therapy with the possibility of 21-day dosing.