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

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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.

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Acknowledgments

During the peer-review process, the manufacturer of BAY 81-8973 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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Authors and Affiliations

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

    Gillian M. Keating

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  1. Gillian M. Keating
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Correspondence to Gillian M. Keating.

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Funding

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

Conflict of interest

Gillian Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: M.E. Mancuso, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy; M. Serban, Department of Pediatrics, University of Medicine and Pharmacy, Timisoara, Romania.

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Keating, G.M. BAY 81-8973 (Octocog Alfa; Kovaltry®): A Review in Haemophilia A. BioDrugs 30, 453–459 (2016). https://doi.org/10.1007/s40259-016-0191-4

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  • DOI: https://doi.org/10.1007/s40259-016-0191-4

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