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: 15 Jan 2024
Price :
$35
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At a glance
- Drugs Bromelains (Primary)
- Indications Burns
- Focus Registrational; Therapeutic Use
- Sponsors MediWound
- 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 a MediWound media release,This 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 a MediWound media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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 European Commission, which is expected imminently.