title: 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.
authors: Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. demail@springer.com.
authors: Gillian M
authors: GM
authors: Keating
mesh_terms: D004305:Dose-Response Relationship, Drug; D005169:Factor VIII / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D006467:Hemophilia A / Q000188:drug therapy*; D006801:Humans; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C078147:F8 protein, human; D005169:Factor VIII