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A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Trial Profile

A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 May 2025

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At a glance

  • Drugs Efgartigimod alfa (Primary) ; Hyaluronidase
  • Indications Chronic inflammatory demyelinating polyradiculoneuropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms ADHERE
  • Sponsors argenx

Most Recent Events

  • 30 Dec 2025 According to an Halozyme Therapeutics media release, argenx VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), has been granted regulatory approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) based on data from this study.
  • 28 Apr 2025 According to an Halozyme Therapeutics media release, company announced that argenx received a positive opinion from the CHMP of the European Medicines Agency recommending European Commission (EC) approval of efgartigimod alfa 1000mg developed with ENHANZE. The CHMP recommendation is based on positive results from the ADHERE clinical trial, The EC is expected to make a decision and the decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein.
  • 27 Feb 2025 According to an argenx media release, PFS decision on approval for CIDP in the EU expected in first half of 2025. PFS decision on approval for gMG and CIDP expected in Japan and Canada in second half of 2025.

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