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A phase 3 safety study of Viaskin Peanut for the treatment of peanut allergic toddlers ages 1 – 3-years

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A phase 3 safety study of Viaskin Peanut for the treatment of peanut allergic toddlers ages 1 – 3-years

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Dec 2024

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At a glance

  • Drugs Peanut allergy immunotherapy (Primary)
  • Indications Peanut hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Acronyms COMFORT Toddlers
  • Sponsors DBV Technologies

    • Most Recent Events

    • 11 Dec 2024 According to a DBV Technologies media release, COMFORT Toddlers study on-track to initiate in 2Q 2025
    • 11 Dec 2024 According to a DBV Technologies media release, company announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 to 3 years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 to 3 years old. DBV and FDA have agreed on the key.
    • 22 Oct 2024 According to a DBV Technologies media release, DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 - 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance.

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