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Acquired haemophilia A (AHA) is a rare, often severe, auto‐immune bleeding disorder caused by the development of inhibitory antibodies (inhibitors) to factor VIII (FVIII). Bypassing agents, recombinant activated FVII or activated prothrombin complex concentrate, are currently recommended as first‐line treatments to control bleeding events in patients with AHA.

A plasma‐derived porcine FVIII (Hyate:C, Ipsen, UK) was used as a first‐line treatment for AHA but was discontinued in 2004 due to viral safety concerns. A recombinant pFVIII (rpFVIII), Obizur (OBI‐1; BAX801), which is expected to have a similar efficacy profile to Hyate:C but with a superior safety profile was developed and recently approved by the US Food and Drug Administration for the treatment of AHA.

Obizur manufacturing begins with the expression of B domain deleted rpFVIII by genetically modified baby hamster kidney …