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Articles by Argenx BV

Review of the European Union Clinical Trials Regulation: Key Early Learnings from the United Kingdom Drug Information Association Medical Writing Committee | Therapeutic Innovation & Regulatory Science

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By Argenx BV, Dicken D. H, Gsk Hq
| link.springer.com
Abstract The European Union Clinical Trials Regulation (EU CTR) provides new regulatory requirements for the preparation and submission of clinical trial documents. The United Kingdom Drug Information Association Medical Writing (UK DIA MW) Committee, with members from across the pharmaceutical industry, have reviewed the EU CTR and in this report, provide expert guidance on writing documents for submission in the EU CTR Clinical Trials Information System (CTIS) portal.
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Efgartigimod and Ravulizumab for Treating Acetylcholine Receptor Auto-antibody-Positive (AChR-Ab+) Generalized Myasthenia Gravis: Indirect Treatment Comparison | Advances in Therapy

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By Van den Steen, A. Gordon, De Francesco, Argenx BV
| link.springer.com
Abstract Efgartigimod and ravulizumab, both approved for treating acetylcholine receptor auto-antibody-positive (AChR-Ab+) generalized myasthenia gravis (gMG), have not been directly compared. This paper assessed comparative effects of efgartigimod vs. ravulizumab for treating adults with AChR-Ab+ gMG using indirect treatment comparison methods. The matching-adjusted indirect comparison used data from two randomized trials of adult men and women. The ADAPT (efgartigimod vs.
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People Diagnosed with Myasthenia Gravis have Lower health-related quality of life and Need More Medical and Caregiver Help in Comparison to the General Population: Analysis of Two Observational Studies - Advances in Therapy

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By De Ruyck, Argenx BV
| link.springer.com
Datasets Two observational, digital, international studies have been conducted among members of the general population diagnosed with MG: (1) the General Population Norms study (POPUP), and (2) the MyRealWorld-MG study (MRW). Sample sizes in both studies were not based on formal calculation but driven by the aim of representativity for the general population and by feasibility for MRW.
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