256 Chapter 7 32. Oosterhoff, J. J., Larsen, M. D., Van Der Schoot, C. E. & Vidarsson, G. Afucosylated IgG responses in humans – structural clues to the regulation of humoral immunity. Trends Immunol. 43, 800–814 (2022). 33. Howard, J. F. et al. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo- controlled, phase 3 trial. Lancet Neurol. 20, 526–536 (2021). 34. argenx. Efgartigimod. argenx.nl https://www.argenx.nl/pipeline/efgartigimod?page=6&allow=1. 35. argenx. argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy. argenx.com https://www.argenx.com/news/ argenx-announces-fda-approval-vyvgart-hytrulo- chronic-inflammatory-demyelinating-polyneuropathy (2024). 36. MDSAS. Immunoglobulin Database Data Update 2020/21. (2022). 37. MDSAS. Immunoglobulin Database Annual Report 2022/2023. (2024). 38. Marketing Research Bureau. DATA & ANALYSIS OF IMMUNOGLOBULIN SUPPLY AND PLASMA REQUIREMENTS IN EUROPE 2010-2021. Revised May 19 2023. https:// marketingresearchbureau.com/wp- content/uploads/2023/05/MRB_EU_SOHO_Figures-2023.pdf. 39. SUPPLY Work Package 6. A Comparative Analysis on the Current Use of Immunoglobulins in Individual Countries: A Clinical Program. 1–149 https://supply-project. eu/wp-content/uploads/2024/02/D6.1-Analysis-report-on-the-current-use-of- immunoglobulins-in-individual-countries.pdf. 40. SUPPLY Work Package 6. Final Recommendations to Achieve Appropriate and Prioritised Use of Immunoglobulins in Europe. 1–46 https://supply-project.eu/wp- content/ uploads/2024/02/D6.2-Recommendation-report-enabling-informed-and- appropriate-prioritisation-on-national-level.pdf. 41. European Commission. New EU rules on substances of human origin. European Commission https://health.ec.europa.eu/blood-tissues-cells-and-organs/overview/new- eu-rules-substances-human- origin_en#:~:text=On%2024%20April%202024%2C%20 the,origin%20intended%20fo r%20human%20application.&text=The%20final%20 text%20of%20the,was%20tabled %20in%20July%202022. (2024). 42. European Commission. Commission welcomes European Parliament’s adoption of the European Health Data Space and regulation on substances of human origin. European Commission: Press corner https://ec.europa.eu/commission/presscorner/ detail/en/IP_24_2250 (2024). 43. Sanquin Blood Supply Foundation. Sanquin Blood Supply Foundation, Annual Report 2021. https://www.sanquin.org/about-sanquin/publications/annual-reports. 44. Vintura. Green Paper: Appropriate Use of Immunoglobulins. https://www.vintura.com/ news/green-paper-appropriate-use-of-immunoglobulins/ (2023).
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