BAY 81-8973 (Octocog Alfa; Kovaltry®): A Review in Haemophilia A

Abstract

BAY 81-8973 (octocog alfa; Kovaltry) is an unmodified, full-length, recombinant factor VIII (FVIII) concentrate with the same amino acid sequence as Kogenate FS, but produced with innovative manufacturing technologies. This narrative review discusses the clinical efficacy and tolerability of BAY 81-8973 in haemophilia A, as well as summarizing its pharmacological properties. Results of the LEOPOLD I, LEOPOLD II and LEOPOLD Kids trials demonstrated that routine prophylaxis with intravenous BAY 81-8973 was associated with a low annualized bleeding rate (ABR) in previously treated adult and paediatric patients with severe haemophilia A. In terms of the ABR, BAY 81-8973 prophylaxis was more effective than on-demand treatment. Intravenous BAY 81-8973 was generally well tolerated, with no inhibitor development reported in previously treated patients in the completed LEOPOLD trial programme. In conclusion, BAY 81-8973 is a useful option for prophylaxis and treatment in adult and paediatric patients with haemophilia A.

Comparative pharmacokinetics of Kogenate FS and Kovaltry in 14 Chinese paediatric patients with haemophilia A: A single‐centre study

“…Kovaltry (BAY 81‐8973, Berkeley, CA, USA) is an unmodified, full‐length, recombinant FVIII. It has the same amino acid sequence as that of Kogenate FS, but has glycan with higher branched structures and higher sialylation 5 . In previous PK studies, Kovaltry has been shown to have better PK characteristics such as prolonged terminal half‐life (t 1/2 ), slower clearance (CL) and longer mean residence time (MRT) after intravenous injection when compared to Kogenate FS or other commercial, unmodified, full‐length rFVIII concentrates such as Advate (Baxalta, Westlake Village, CA, USA) 6 .…”

Pharmacokinetic study of Kovaltry in thirty‐five pediatric patients aged <12 years with severe hemophilia A

“…Since Kovaltry has been approved to treat haemophilia A in different countries and regions, a large number of haemophiliac patients take it in daily prophylaxis. Although its efficacy and safety have been reported previously, the PK profiles have not been presented, and the clinical outcomes were limited in paediatric patients aged <12 years old 13 . Therefore, in this study, we analysed PK data and clinical outcomes of 35 paediatric patients with severe haemophilia A.…”

“…Although its efficacy and safety have been reported previously, the PK profiles have not been presented, and the clinical outcomes were limited in paediatric patients aged <12 years old. 13 Therefore, in this study, we analysed PK data and clinical outcomes of 35 paediatric patients with severe haemophilia A.…”

Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates

“…In some previous studies, Kovaltry was reported with enhanced PK profiles, which might bring improved clinical outcomes compared with other SHL FVIII concentrates. 14…”