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A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE)

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Trial Profile

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2022

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At a glance

  • Drugs Tezepelumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms SOURCE
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 09 Nov 2022 Data from 3 studies (NCT03401229, NCT03347279 and NCT03406078) was used to evaluate the changes in patients behavior throughout a longer study with respect to daily Patient-Reported Outcomes were presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 25 Jul 2022 According to an AstraZeneca media release, based on results from the PATHFINDER clinical trial programme (NAVIGATOR and SOURCE)The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of marketing authorisation application in EU as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
    • 07 Jul 2021 According to an Amgen media release, U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022.
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