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Lonoctocog Alfa: A Review in Haemophilia A
online resourceposted on 05.04.2018, 02:19 by Zaina Al-Salama, Lesley Scott
Compliance with Ethical Standards
Funding: The preparation of this review was not supported by any external funding.
Conflicts of interest: Zaina T. Al-Salama and Lesley J. Scott are salaried employee of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found here.
Lonoctocog alfa (rVIII-SingleChain; Afstyla®) is a novel single-chain recombinant factor VIII (FVIII) molecule, with a truncated B-domain and the heavy and light chains covalently linked to form a stable and homogenous drug that binds with high affinity to von Willebrand factor (VWF). Intravenous lonoctocog alfa is approved for the prophylaxis and treatment of bleeding in patients with haemophilia A in several countries worldwide. In two pivotal, multicentre trials, lonoctocog alfa was effective in the treatment of bleeding episodes and as prophylaxis, including for perioperative management in adults, adolescents and children. In terms of haemostatic efficacy in controlling bleeding episodes, overall treatment and investigator-assessed success rates were high across all age groups, with the majority of these bleeds controlled with a single injection of lonoctocog alfa. Low median spontaneous, overall and traumatic annualized bleeding rates were evident with prophylactic lonoctocog alfa regimens in both trials. Lonoctocog alfa was generally well-tolerated, with very low rates of injection-site reactions. No previously treated patient experienced an anaphylactic reaction or developed an inhibitor. In conclusion, lonoctocog alfa is an effective and generally well-tolerated alternative to conventional FVIII products for the treatment and prophylaxis of bleeding, including in the surgical setting, in adults, adolescents and children with haemophilia A. Access to the full article can be found here.
© Springer International Publishing AG, part of Springer Nature 2017