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A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment

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Trial Profile

A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment

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

Latest Information Update: 15 Jan 2024

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At a glance

  • Drugs Bromelains (Primary) ; Bromelains (Primary)
  • Indications Burns
  • Focus Registrational; Therapeutic Use
  • Acronyms CIDS
  • Sponsors MediWound

    • Most Recent Events

    • 09 Jan 2024 According to a MediWound media release, the USFDA has completed their filing review and accepted a supplement to the NexoBrid sBLA for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns, The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of CIDS study as well as additional pediatric data available from Phase 3 and Phase 2 studies.
    • 13 Nov 2023 According to aMediWound media release, the positive opinion is based on the results of this trial and pediatric data available from Phase 3 and Phase 2 studies.
    • 13 Nov 2023 According to aMediWound media release,company announced that the CHMP of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial and full-thickness thermal burns.The CHMP positive opinion is pending a decision by the EC,which is expected imminently.
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