IB1001

IB1001 is a recombinant Factor IX (rFIX) therapy developed for the treatment and prevention of bleeding episodes in patients with hemophilia B. As a replacement therapy, it functions by supplying the clotting factor IX that is deficient or dysfunctional in individuals with this X-linked genetic disorder, thereby restoring the coagulation cascade and promoting hemostasis. Originally developed by Inspiration Biopharmaceuticals and Ipsen, the rights were acquired by Cangene Corporation in 2013. The product underwent Phase 3 clinical evaluation but faced significant regulatory hurdles, including an FDA clinical hold due to the development of antibodies against host cell proteins and a subsequent Complete Response Letter in 2013 regarding manufacturing and development data. The European Marketing Authorization Application was also withdrawn in 2013.

Brand names

Ixinity

Other names

recombinant factor IXrFIXrecombinant coagulation factor IX