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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2024

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At a glance

  • Drugs Rozanolixizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms MycarinG study
  • Sponsors UCB Biopharma

    • Most Recent Events

    • 12 Apr 2024 According to an UCB media release, data from the study will be presented at the 76th American Academy of Neurology (AAN) Annual Meeting, April 13-18, 2024, in Denver, Colorado, USA.
    • 08 Jan 2024 According to an UCB media release, company announced that the European Commission has granted a marketing authorization for rozanolixizumab on 5th January 2024 as an add-on to standard therapy for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Approval of this orphan medicinal product is based on this trial.
    • 10 Nov 2023 According to an UCB media release,Rozanolixizumab is currently under review by the Center of Drug Evaluation of the China National Medical Products Administration, the Australian Therapeutic Goods Administration (TGA), Health Canada and Switzerland (Swissmedic) for the treatment of adults with gMG. Responses from regulatory agencies to these submissions are expected during H2 2023 and H1 2024.
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