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Coagulation Factor IX (Recombinant), Albumin Fusion Protein (Albutrepenonacog Alfa; Idelvion®): A Review of Its Use in Haemophilia B

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Abstract

Albutrepenonacog alfa (Idelvion®), a fusion protein that genetically fuses recombinant factor IX (rFIX) with recombinant human albumin (rAlbumin), is indicated in the treatment of haemophilia B. This narrative review discusses the pharmacological properties and clinical data related to the use of this novel fusion protein, hereafter referred to as rIX-FP. The fusion of rFIX to rAlbumin prolongs the elimination half-life of rIX-FP in the circulation, allowing routine prophylaxis to be administered once every 7–14 days. In the pivotal phase 3 clinical trials in previously treated patients with moderately severe to severe haemophilia B, routine rIX-FP prophylaxis (administered once every 7 days in children, and once every 7–14 days in adolescents and adults) was associated with low annualized spontaneous, total and joint bleeding rates, and was associated with significantly fewer bleeding episodes than on-demand treatment. rIX-FP was also effective in controlling bleeding episodes when used as on-demand treatment and in maintaining haemostasis in the perioperative setting. rIX-FP was well tolerated in the clinical trials, with no reports of inhibitor development. In conclusion, rIX-FP provides an effective, well-tolerated option for the treatment and management of haemophilia B that, by virtue of its extended half-life, is less burdensome than conventional FIX products.

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Acknowledgements

During the peer review process, the manufacturer and market authorization holders of rIX-FP (Idelvion®) were 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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    Katherine A. Lyseng-Williamson

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  1. Katherine A. Lyseng-Williamson
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Correspondence to Katherine A. Lyseng-Williamson.

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

Conflict of interest

Katherine A. Lyseng-Williamson 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: L.N. Boggio, Rush Hemophilia and Thrombophilia Center, Rush University, Chicago, IL, USA; G. Castaman, Center for Bleeding Disorders and Coagulation, Department of Oncology, Careggi University Hospital, Florence, Italy; R. Klamroth, Haemophilia Treatment Centre, Vivantes Hospital, Berlin, Germany; J.N. Mahlangu, Haemophilia Comprehensive Care Centre, Charlotte Maxeke Johannesburg Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; M.E. Mancuso, Angelo Bianchi Bonimi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy; M. Morfini, Past President of Italian Association of Haemophilia Centres (AICE), Florence, Italy.

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Lyseng-Williamson, K.A. Coagulation Factor IX (Recombinant), Albumin Fusion Protein (Albutrepenonacog Alfa; Idelvion®): A Review of Its Use in Haemophilia B. Drugs 77, 97–106 (2017). https://doi.org/10.1007/s40265-016-0679-8

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