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A Randomised, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study)

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Trial Profile

A Randomised, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Benralizumab (Primary) ; Mepolizumab
  • Indications Churg-Strauss syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms MANDARA
  • Sponsors AstraZeneca

Most Recent Events

  • 13 May 2025 According to AstraZeneca media release, data from the study will be presented at at the American Thoracic Society (ATS) International Conference, in San Francisco, CA from May 16 to 21, 2025.
  • 28 Oct 2024 According to AstraZeneca media release, Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use, based on positive results from the MANDARA Phase III trial
  • 23 Sep 2024 According to AstraZeneca media release, Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the MANDARA Phase III trial.

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