The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial thickness and/or full thickness thermal burns.
NexoBrid is a topically administered, bromelain-based biological product containing a sterile mixture of proteolytic enzymes. The product selectively removes burn eschar within 4 hours without harming surrounding viable tissue.
The resubmitted BLA comes after the FDA issued a Complete Response Letter to MediWound in June 2021 requiring additional manufacturing data. The application is supported by the phase 3 DETECT trial (ClinicalTrials.gov Identifier: NCT02148705), which compared NexoBrid to gel vehicle placebo or standard of care in adult patients with deep partial and full thickness thermal burns up to 30% of total body surface area (N=175).
Findings from the trial showed that NexoBrid was associated with a higher incidence of complete eschar removal, a shorter time to complete eschar removal, a lower incidence of surgical eschar removal, and reduced blood loss during the eschar removal procedure, compared with standard of care.
“We are thrilled to have our application accepted and to be one step closer to commercializing NexoBrid in the US,” said Ofer Gonen, CEO of MediWound. “We have seen NexoBrid help burn patients worldwide and knowing that it may be soon available in the United States is very gratifying.”
NexoBrid is currently approved in the European Union and other international markets. The FDA is expected to make a decision on the application on January 1, 2023.
MediWound announces US FDA acceptance of Biologics License Application for NexoBrid for the treatment of severe thermal burns. News release. MediWound Ltd. Accessed August 3, 2022. https://www.globenewswire.com/news-release/2022/08/03/2491251/30505/en/MediWound-Announces-U-S-FDA-Acceptance-of-Biologics-License-Application-for-NexoBrid-for-the-Treatment-of-Severe-Thermal-Burns.html