Thursday, September 27, 2012

rFIXFc shows positive data in Hemophilia B patients

rFIXFc being developed by Biogen Idec and Swedish Orphan Biovitrum AB has met the primary endpoint in the Phase 3 study B-LONG in Hemophilia B patients. rFIXFc was able to cut bleeding rates by atleast 50%. rFIXFc was associated with an overall median bleeding rate involving spontaneous and traumatic bleeds of 2.95 in weekly prophylaxis arm, 1.38 in individualized prophylaxis arm as compared to 17.69 in the as needed treatment arm.  There were no inhibitiors to rFIXFc that were detected and there was no anaphhylaxis reported.
Among serious adverse event, there was one case of obstructive uropathy, which was resolved with medical management.
Biogen Idec would submit rFIXFc for approval to the USFDA  in first half 2013.