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An Open-label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children From 6 to 11 Years of Age With Severe Eosinophilic Asthma

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Trial Profile

An Open-label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children From 6 to 11 Years of Age With Severe Eosinophilic Asthma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Aug 2023

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At a glance

  • Drugs Mepolizumab (Primary)
  • Indications Asthma; Eosinophilia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 12 Sep 2019 According to a GlaxoSmithKline media release, the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma.The FDA approval is supported by this study which investigated pharmacokinetics, pharmacodynamics and long-term safety of Nucala (mepolizumab).
    • 16 Aug 2019 Results assessing tolerability of mepolizumab in children with severe asthma, published in the Journal of Allergy and Clinical Immunology.
    • 19 Nov 2018 According to a GlaxoSmithKline media release, the company has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of Nucala (mepolizumab) as an add-on treatment for severe eosinophilic asthma in paediatric patients aged six to 11 years, based on the data from this trial.
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