Date: 2015-12-08
Type of
information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla
Company: Biogen (USA - MA) Swedish Orphan Biovitrum SOBI (Sweden)
Product: Alprolix® (eftrenonacog alfa - long-lasting recombinant Factor IX Fc fusion protein (rFIXFc) - BIIB 029
Action
mechanism:
- fusion protein/coagulation factor. Recombinant FIXFc is a clotting factor developed using Biogen Idec's novel and proprietary monomeric Fc fusion technology, which makes use of a natural pathway to recycle rFIXFc in circulation and enable it to remain in the body longer. With this technology, rFIXFc is designed to provide long-lasting protection from bleeding and reduce the treatment burden associated with hemophilia B, which currently requires more than 100 injections annually for prophylaxis with commercially-available Factor IX products.
Disease: hemophilia B
Therapeutic
area: Rare diseases - Genetic diseases - Hematological diseases
Country:
Trial
details:
Latest
news:
- • On December 8, 2015, Biogen and Swedish Orphan Biovitrum (Sobi) have presented new data at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla. These data demonstrate Elocta®/Eloctate® (efmoroctocog alfa) [recombinant human coagulation factor VIII, Fc fusion protein]) and Alprolix® (rFIXFc) may effectively manage target joint bleeding and maintain low annualised bleeding rates (ABRs) in people with severe haemophilia A and B. For people with severe haemophilia A and B, most bleeding events occur in joints. When bleeding events occur repeatedly in the same joint (known as a target joint), it is often a precursor to chronic joint disease, marked by progressive deterioration of the joint. These post-hoc analyses aimed to assess the frequency of bleeding events and the dosing of Elocta and Alprolix in study participants who had one or more target joint bleeds [major joint (e.g., knee, elbow, ankle) with three or more bleeding episodes in a three-month (haemophilia B) or six-month (haemophilia A) period].
In the B-LONG (the pivotal phase 3 study) post-hoc analysis, for people with haemophilia B taking Alprolix® prophylactically, the therapy was shown effective for reducing the frequency of bleeding episodes overall and in target joints. The analysis found that 48.6 per cent of participants receiving weekly prophylaxis (n=35) and 37.5 per cent of participants on individualised interval prophylaxis (n=8) did not have any target joint bleeds at the end of B-LONG. Overall, participants' target joint, spontaneous target joint and traumatic target joint median ABRs were low for participants in the weekly prophylaxis arm (1.03, 0.00 and 0.00 respectively) and the individualised interval prophylaxis arm (2.20, 2.20 and 0.00 respectively).
Is
general: Yes
