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Enzymatic Debridement in Burns Patients (Children ' Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

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Trial Profile

Enzymatic Debridement in Burns Patients (Children ' Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Aug 2024

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At a glance

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

Most Recent Events

  • 15 Aug 2024 According to a MediWound media release, the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. The submission was supported by the results of a global Phase III clinical trial CIDS as well as additional pediatric data available from Phase III and Phase II studies conducted during the clinical development of NexoBrid.
  • 21 Mar 2024 According to a MediWound media release, the company expects decision on Supplemental BLA for pediatric indication in the second half of 2024.
  • 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.

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