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Susoctocog Alfa: A Review in Acquired Haemophilia A

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An Erratum to this article was published on 10 May 2016

Abstract

Intravenous susoctocog alfa (Obizur®) is a recombinant, B-domain deleted, porcine sequence antihaemophilic factor VIII (FVIII) product that has recently been approved for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA). Intravenous susoctocog alfa was an effective and generally well tolerated treatment for serious bleeding episodes in adult patients with AHA in a multinational, phase II/III trial (n = 28 evaluable). Patients received an initial dose of susoctocog alfa 200 U/kg, with subsequent dosages based on target FVIII trough levels and clinical assessments. All patients had a positive haemostatic response (based on predefined criteria) of the primary bleed 24 h after the first infusion of susoctocog alfa, with the bleed successfully controlled at the time of final dosing in 86 % of patients. The most frequently reported adverse reaction (incidence >5 %) was the development of inhibitory antibodies against susoctocog alfa (porcine FVIII). Overall, 25 % of antibody naive patients developed anti-susoctocog alfa antibodies during the study. No serious treatment-related adverse events, thrombotic events or allergic reactions were reported during the trial. In conclusion, intravenous susoctocog alfa is a useful addition to the limited treatment options available for the management of acute bleeding episodes in adults with AHA.

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References

  1. World Federation of Hemophilia. Acquired hemophilia: revised edition. 2012. http://www.wfh.org. Accessed 29 Mar 2016.

  2. Collins PW, Chalmers E, Hart D, et al. Diagnosis and management of acquired coagulation inhibitors: a guideline from UKHCDO. Br J Haematol. 2013;162(6):758–73.

    Article  CAS  Google Scholar 

  3. Huth-Kuhne A, Baudo F, Collins P, et al. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica. 2009;94(4):566–75.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Oh J, Lim Y, Jang MJ, et al. Characterization of anti-factor VIII antibody in a patient with acquired hemophilia A. Blood Res. 2013;48(1):58–62.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Lillicrap D, Schiviz A, Apostol C, et al. Porcine recombinant factor VIII (Obizur; OBI-1; BAX801): product characteristics and preclinical profile. Haemophilia. 2015. doi:10.1111/hae.12784.

    PubMed Central  Google Scholar 

  6. Parker ET, Craddock HN, Barrow RT, et al. Comparative immunogenicity of recombinant B domain-deleted porcine factor VIII and Hyate: C in hemophilia A mice presensitized to human factor VIII. J Thromb Haemost. 2004;2(4):605–11.

    Article  CAS  PubMed  Google Scholar 

  7. Baxter Healthcare Corporation. Obizur (antihemophilic factor [recombinant], porcine sequence): US prescribing information. 2014. https://www.baxalta.com/. Accessed 11 Apr 2016.

  8. European Medicines Agency. Obizur: summary of product characteristics. 2015. http://www.ema.europa.eu. Accessed 11 Apr 2016.

  9. Baxalta Incorporated. Baxalta gains health Canada approval for OBIZUR to treat patients with acquired hemophilia A [media release]. 15 October 2015. http://www.baxalta.com.

  10. European Medicines Agency. European public assessment report (EPAR) for Obizur. 2015. http://www.ema.europa.eu. Accessed 29 Mar 2016.

  11. Negrier C, Oldenburg J, Poetzsch B, et al. Recombinant porcine sequence FVIII corrects thrombin generation and improves clot structure in plasma from hemophilia A patients with inhibitors [abstract no. 93]. Am J Hematol. 2014;89(6):E44–5.

    Google Scholar 

  12. Schiviz A, Piskernik C, Leidenmuehler P, et al. Efficacy of OBI-1, a recombinant porcine sequence FVIII product, in animal models of hemophilia A [abstract]. Haemophilia. 2014;20(Suppl 3):2.

    Google Scholar 

  13. Baxalta Innovations GmbH. OBI-1-201 Study report May 30, 2008. 2008. http://www.baxalta.com/. Accessed 29 Mar 2016.

  14. Mahlangu J, Andreeva T, Macfarlane D. A phase II open-label study evaluating the hemostatic activity, pharmacokinetics and safety of recombinant porcine factor VIII (OBI-1) in hemophilia A patients with inhibitors directed against human FVIII [abstract no. 03 PO 43]. Haemophilia. 2008;14(Suppl. 2):15–6.

    Google Scholar 

  15. Kruse-Jarres R, St-Louis J, Greist A, et al. Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A. Haemophilia. 2015;21(2):162–70.

    Article  CAS  PubMed  Google Scholar 

  16. Allacher P, Horling F, Piskernik C, et al. Non-clinical immunogenicity assessment of a new recombinant porcine sequence FVIII (OBI-1) [abstract]. Haemophilia. 2014;20(Suppl 3):2.

    Google Scholar 

  17. Kempton CL, Abshire TC, Deveras RA, et al. Pharmacokinetics and safety of OBI-1, a recombinant B domain-deleted porcine factor VIII, in subjects with haemophilia A. Haemophilia. 2012;18(5):798–804.

    Article  CAS  PubMed  Google Scholar 

  18. Novack A, St-Louis J, Greist A, et al. Perioperative management of bleeds with recombinant porcine FVIII in patients with acquired hemophilia A [abstract no. OR028]. J Thromb Haemost. 2015;13(Suppl 2):104.

    Google Scholar 

  19. Jenkins PV, Rawley O, Smith OP, et al. Elevated factor VIII levels and risk of venous thrombosis. Br J Haematol. 2012;157(6):653–63.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgments

During the peer review process, the manufacturer of susoctocog alfa was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Celeste B. Burness & Lesley J. Scott

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  1. Celeste B. Burness
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  2. Lesley J. Scott
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Correspondence to Celeste B. Burness.

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Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Celeste B. Burness and Lesley J. Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: E. Berntorp, Malmö Centre for Thrombosis and Haemostasis, Lund University, Malmö, Sweden; A. Bianchi, Bonomi Hemophilia and Thrombosis Center, IRCCS Fondazione Ca’ Granda, Maggiore Hospital, Milan, Italy; C. Hermans, Division of Haematology Haemostasis and Thrombosis Unit Haemophilia Clinic, St-Luc University Hospital, Brussels, Belgium; M. E. Mancuso, Bonomi Hemophilia and Thrombosis Center, IRCCS Fondazione Ca’ Granda, Maggiore Hospital, Milan, Italy; P.M. Mannucci, IRCCS Ca’ Granda Maggiore Policlinico Hospital Foundation, Milan, Italy

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Burness, C.B., Scott, L.J. Susoctocog Alfa: A Review in Acquired Haemophilia A. Drugs 76, 815–821 (2016). https://doi.org/10.1007/s40265-016-0576-1

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