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A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2024

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At a glance

  • Drugs Dupilumab (Primary) ; Beta-adrenergic receptor agonists; Corticosteroid; Muscarinic receptor antagonists
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BOREAS
  • Sponsors Sanofi

    • Most Recent Events

    • 26 Apr 2024 According to a Sanofi media release, findings across six abstracts from the BOREAS phase 3 study will be presented at the American Thoracic Society (ATS) International Conference taking place from May 17-22 in San Diego.
    • 23 Feb 2024 According to a Sanofi media release, based on positive results from two phase 3 clinical studies (BOREAS and NOTUS) US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is Jun 27 2024.
    • 01 Feb 2024 According to a Sanofi media release, supplemental Biologics License Application (sBLA) of Dupixent (dupilumab) in Chronic Obstructive Pulmonary Disease (COPD) in the U.S. was completed in December 2023 and for China in 2024, following its Marketing Authorization Application (MAA) submission in Europe. The submission was based on positive interim results from NOTUS, along with positive results from BOREAS.
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