Susoctocog Alfa: A Review in Acquired Haemophilia A

Drugs. 2016 May;76(7):815-21. doi: 10.1007/s40265-016-0576-1.

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.

Publication types

  • Review

MeSH terms

  • Administration, Intravenous
  • Animals
  • Antibodies / blood
  • Clinical Trials as Topic
  • Factor VIII / immunology
  • Factor VIII / therapeutic use*
  • Hemophilia A / drug therapy*
  • Hemorrhage / drug therapy
  • Humans
  • Mice
  • Recombinant Proteins / immunology
  • Recombinant Proteins / therapeutic use
  • Swine

Substances

  • Antibodies
  • Recombinant Proteins
  • Factor VIII

Supplementary concepts

  • Factor 8 deficiency, acquired