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A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis

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Trial Profile

A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2024

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At a glance

  • Drugs Efgartigimod alfa (Primary) ; Efgartigimod alfa
  • Indications Myasthenia gravis
  • Focus Pharmacodynamics; Registrational
  • Acronyms ADAPT-SC
  • Sponsors argenx

Most Recent Events

  • 31 Oct 2024 According to an argenx media release, FDA review of VYVGART SC pre-filled syringe (PFS) for gMG and CIDP ongoing with Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2025.
  • 16 Jul 2024 According to argenx media release. company announced that Chinas National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimod alfa injection based on result of ADAPT and ADAPT-SC study
  • 18 Apr 2024 Interim Results (As of December 2022, n=179) assessing long-term safety, tolerability, and efficacy of Efgartigimod PH20 in Participants with Generalized Myasthenia Gravis presented at the 76th Annual Meeting of the American Academy of Neurology 2024

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