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A study to assess safety, tolerability and Pharmacokinetics of Tofersen in adults for the treatment of amyotrophic lateral sclerosis (ALS) due to SOD1 mutations

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Trial Profile

A study to assess safety, tolerability and Pharmacokinetics of Tofersen in adults for the treatment of amyotrophic lateral sclerosis (ALS) due to SOD1 mutations

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Mar 2024

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At a glance

  • Drugs Tofersen (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Biogen

    • Most Recent Events

    • 23 Feb 2024 According to a Biogen media release, the CHMP's recommendation for QALSODY will now be reviewed by the EC for a decision on a marketing authorization in the European Union, with a decision expected in the second quarter of 2024.
    • 23 Feb 2024 According to a Biogen media release, company announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY (tofersen) for the treatment of adults with amyotrophic lateral sclerosis, associated with a mutation in the superoxide dismutase 1 gene.
    • 23 Jan 2023 According to a Biogen media release, the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee for the New Drug Application (NDA) for tofersen for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).

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