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argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

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  • argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG)
  • Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of Vyvgart (QW × 4wks) with 4wks. interval btw cycles, then additional cycles per clinical status
  • Trial met its 1EP of improved MG-ADL scores; argenx plans an sBLA submission at 2025 end to expand Vyvgart’s label to adult AchR-Ab seronegative gMG (MuSK+, LRP4+, triple negative), with full data to be presented at a medical meeting

Ref: Argenx Image: Argenx | Press Release

Related News:- Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

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