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A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children

Trial Profile

A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2019

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At a glance

  • Drugs Peanut allergy immunotherapy (Primary)
  • Indications Peanut hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Acronyms PEPITES
  • Sponsors DBV Technologies
  • Most Recent Events

    • 24 Oct 2019 According to a DBV Technologies media release, data from this trial will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Houston, Texas, November 7-11, 2019.
    • 04 Oct 2019 According to an DBV media release, the U.S. Food and Drug Administration(FDA) has accepted for review the Biologics License Application(BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years. The target action date provided by the FDA is August 5, 2020. The FDA has communicated that it is currently planning to hold an advisory committee meeting to discuss the Viaskin Peanut application.
    • 25 Feb 2019 Results of pooled post-hoc analysis from PEPITES and REALISE studies presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
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