Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BioDrugs
Published in: BioDrugs 5/2016

01-10-2016 | Adis Drug Evaluation

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

Author: Gillian M. Keating

Published in: BioDrugs | Issue 5/2016

Login to get access

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.
Literature
1.
Peyvandi F, Garagiola I, Young G. The past and future of haemophilia: diagnosis, treatments, and its complications. Lancet. 2016;388(10040):187–97.CrossRefPubMed
2.
Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1–47.CrossRefPubMed
3.
Shah A, Delesen H, Garger S, et al. Pharmacokinetic properties of BAY 81-8973, a full-length recombinant factor VIII. Haemophilia. 2015;21(6):766–71.CrossRefPubMed
4.
5.
6.
Vogel JH, Huesslein A, Goudar C, et al. BAY 81-8973: a new full-length recombinant FVIII product using novel manufacturing technologies [abstract no. 08P40]. Haemophilia. 2010;16(Suppl 4):40.
7.
Humphries T, Regan L, Garger S, et al. BAY 81-8973: a new third-generation rFVIII created through state-of-the-art manufacturing, offering dosing flexibility to the hemophilia A community [abstract]. Haemophilia. 2015;21(3):e264.
8.
9.
Saxena K, Lalezari S, Oldenburg J, et al. Efficacy and safety of BAY 81-8973, a full-length recombinant factor VIII: results from the LEOPOLD I trial. Haemophilia. 2016. doi:10.​1111/​hae.​12952.PubMed
10.
Kavakli K, Yang R, Rusen L, et al. Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II). J Thromb Haemost. 2015;13(3):360–9.CrossRefPubMedPubMedCentral
11.
Ljung R, Kenet G, Mancuso ME, et al. BAY 81-8973 safety and efficacy for prophylaxis and treatment of bleeds in previously treated children with severe haemophilia A: results of the LEOPOLD Kids Trial. Haemophilia. 2016;22(3):354–60.CrossRefPubMed
12.
Kitchen S, Katterle Y, Beckmann H, et al. Chromogenic assay for BAY 81-8973 potency assignment has no impact on clinical outcome or monitoring in patient samples. J Thromb Haemost. 2016;14(6):1192–9.CrossRefPubMed
13.
Kitchen S, Beckmann H, Katterle Y, et al. BAY 81-8973, a full-length recombinant factor VIII: results from an international comparative laboratory field study. Haemophilia. 2016;22(3):e192–9.CrossRefPubMed
14.
Oldenburg J, Windyga J, Hampton K, et al. Safety and efficacy of BAY 81-8973 for surgery in previously treated patients with haemophilia A: results of the LEOPOLD clinical trial programme. Haemophilia. 2016;22(3):349–53.CrossRefPubMed
15.
Ljung R, Fischer K, Carcao M, et al. Practical considerations in choosing a factor VIII prophylaxis regimen: role of clinical phenotype and trough levels. Thromb Haemost. 2016;115(5):913–20.CrossRefPubMed
16.
Dodt J, Hubbard AR, Wicks SJ, et al. Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators. Haemophilia. 2015;21(4):543–9.CrossRefPubMed
17.
Gouw SC, van den Berg HM, Fischer K, et al. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study. Blood. 2013;121(20):4046–55.CrossRefPubMed
18.
Calvez T, Chambost H, Claeyssens-Donadel S, et al. Recombinant factor VIII products and inhibitor development in previously untreated boys with severe hemophilia A. Blood. 2014;124(23):3398–408.CrossRefPubMed
19.
Collins PW, Palmer BP, Chalmers EA, et al. Factor VIII brand and the incidence of factor VIII inhibitors in previously untreated UK children with severe hemophilia A, 2000-2011. Blood. 2014;124(23):3389–97.CrossRefPubMedPubMedCentral
20.
Vézina C, Carcao M, Infante-Rivard C, et al. Incidence and risk factors for inhibitor development in previously untreated severe haemophilia A patients born between 2005 and 2010. Haemophilia. 2014;20(6):771–6.CrossRefPubMed
21.
Fischer K, Lassila R, Peyvandi F, et al. Inhibitor development in haemophilia according to concentrate: four-year results from the European HAemophilia Safety Surveillance (EUHASS) project. Thromb Haemost. 2015;113(5):968–75.CrossRefPubMed
22.
23.
Coyle TE, Reding MT, Lin JC, et al. Phase I study of BAY 94-9027, a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A. J Thromb Haemost. 2014;12(4):488–96.CrossRefPubMedPubMedCentral
Metadata
Title
BAY 81-8973 (Octocog Alfa; Kovaltry®): A Review in Haemophilia A
Author
Gillian M. Keating
Publication date
01-10-2016
Publisher
Springer International Publishing
Published in
BioDrugs / Issue 5/2016
Print ISSN: 1173-8804
Electronic ISSN: 1179-190X
DOI
https://doi.org/10.1007/s40259-016-0191-4

Other articles of this Issue 5/2016

BioDrugs 5/2016 Go to the issue

Adis Drug Evaluation

Infliximab Biosimilar (CT-P13; Infliximab-dyyb): A Review in Autoimmune Inflammatory Diseases

Erratum

Erratum to: Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases

Original Research Article

Reduction of Isoagglutinin in Intravenous Immunoglobulin (IVIG) Using Blood Group A- and B-Specific Immunoaffinity Chromatography: Industry-Scale Assessment

Adis Drug Evaluation

Talimogene Laherparepvec: A Review in Unresectable Metastatic Melanoma

Erratum

Erratum to: Recent Progress in JAK Inhibitors for the Treatment of Rheumatoid Arthritis

Review Article

Advances in the Treatment of Non–small Cell Lung Cancer: Focus on Nivolumab, Pembrolizumab, and Atezolizumab