Efmoroctocog Alfa: A Review in Haemophilia A.

Abstract

Efmoroctocog alfa (Elocta®, Eloctate®, Eloctate™), an extended half-life (EHL) recombinant factor VIII (rFVIII)-Fc fusion protein, is approved for the treatment and prophylaxis of bleeding in patients with haemophilia A. The efficacy of efmoroctocog alfa in the prevention and treatment of bleeding in previously treated patients (PTPs) and previously untreated patients (PUPs) with severe haemophilia A has been demonstrated in phase III studies; this includes its use in the perioperative setting (in PTPs). Furthermore, the effectiveness of efmoroctocog alfa in clinical practice has been confirmed in numerous real-world studies; compared with conventional, standard half-life (SHL) FVIII products, prophylaxis with this EHL FVIII product achieved similar or reduced bleeding rates with fewer injections. Efmoroctocog alfa was generally well tolerated; inhibitors occurred in approximately one-third of PUPs in a phase III study. Efmoroctocog alfa is an established and effective EHL FVIII replacement therapy for the management of haemophilia A. Compared with SHL FVIII products, EHL FVIII products such as efmoroctocog alfa have the potential to optimise prophylactic outcomes by decreasing the burden of treatment or increasing the level of bleed protection.

• Authors: James E Frampton
• Journal: Drugs (Drugs) Vol. 81 Issue 17 Pg. 2035-2046 (Nov 2021) ISSN: 1179-1950 [Electronic] New Zealand
• PMID: 34743314 (Publication Type: Journal Article, Review)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

Chemical References

• Immunoglobulin Fc Fragments
• Recombinant Fusion Proteins
• factor VIII-Fc fusion protein
• Factor VIII

Topics

• Area Under Curve
• Clinical Trials, Phase III as Topic
• Factor VIII (adverse effects, pharmacokinetics, therapeutic use)
• Half-Life
• Hemophilia A (drug therapy)
• Hemorrhage (prevention & control)
• Humans
• Immunoglobulin Fc Fragments (adverse effects, therapeutic use)
• Male
• Metabolic Clearance Rate
• Recombinant Fusion Proteins (adverse effects, pharmacokinetics, therapeutic use)