Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI-1 is an investigational, B-domain deleted, recombinant FVIII, porcine sequence, with low cross-reactivity to anti-hFVIII antibodies. Efficacy can be monitored with FVIII activity …

2024年12月25日 · OBI1 (ORC Ubiquitin Ligase 1) is a Protein Coding gene. Diseases associated with OBI1 include Bladder Small Cell Carcinoma and Factor Viii Deficiency. E3 ubiquitin ligase essential for DNA replication origin activation during S phase (PubMed: 31160578).

Obizur is a highly purified recombinant porcine FVIII drug product that has been demonstrated to have a favourable safety and efficacy profile when compared with Hyate:C and can be a valuable treatment option for control of bleeding in AHA patients.

重组pFVIII（rpFVIII），Obizur（OBI-1; BAX801）有望与Hyate：C具有相似的功效，但安全性更高，因此已开发出来，最近获得了美国食品药品监督管理局的批准。

OBI-1 is a recombinant B-domain deleted porcine factor VIII (FVIII). FVIII treatment in those with haemophilia A may be complicated by the development of anti-FVIII antibodies (inhibitors) leading to a failure to respond to treatment with human FVIII.

2022年6月16日 · Obizur（Susoctocog alfa）是目前首个美国食品药品监督管理局（FDA）以及欧洲药品管理局（EMA） [1]， [2] 批准用于获得性血友病A的重组猪FⅧ（rpFⅧ）药物，有望为中国获得性血友病A患者提供新的治疗选择。 获得性血友病A是一种获得性出血性疾病，患者由于循环血中出现抗凝血因子Ⅷ自身抗体导致FⅧ活性降低，其特点为既往无出血史和无阳性家族史的患者出现自发性出血或者在手术、外伤或侵入性检查时发生异常出血，年发病率约为1.5/100万 [3] …

2015年1月27日 · OBI-1 is an investigational, B-domain deleted, recombinant FVIII, porcine sequence, with low cross-reactivity to anti-hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments.

2012年11月16日 · OBI-1 is an investigational B-domain deleted recombinant porcine factor VIII (FVIII) with low cross-reactivity to anti-human FVIII antibodies. Acquired hemophilia A (AHA) is caused by autoantibodies (inhibitors) against human FVIII.

2015年12月3日 · The recombinant porcine FVIII (rpFVIII), OBI-1, recently obtained regulatory approval based on the results of Phase 2/3 trial, but the patients in this cohort did not have GIBs. Here we present a patient with AHA admitted with a GIB and successfully treated with OBI-1.

2010年8月6日 · 本研究旨在检验研究药物 (obi-1) 是否安全有效地治疗获得性血友病 a 患者的严重出血事件。