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A phase 1 PK/PD study of natalizumab in relapsing-remitting multiple sclerosis

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Trial Profile

A phase 1 PK/PD study of natalizumab in relapsing-remitting multiple sclerosis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Sep 2023

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At a glance

  • Drugs Natalizumab (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Registrational

    • Most Recent Events

    • 26 Sep 2023 According to a Novartis media release, company announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by Polpharma Biologics. Decision based on evidence from extensive analytical characterization demonstrating similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies.
    • 24 Jul 2023 According to a Polpharma Biologics media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion regarding granting marketing authorization for natalizumab for the treatment of multiple sclerosis. The MAA submission was supported by a robust analytical, preclinical and clinical data package including data from this and Antelope trial.
    • 16 Sep 2022 New trial record

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