MediWound (MDWD) Announces FDA Acceptance of BLA for NexoBrid

MediWound Ltd. (Nasdaq: MDWD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently re-submitted Biologics License Application (BLA) for NexoBrid^® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of January 1, 2023.

“We are thrilled to have our application accepted and to be one step closer to commercializing NexoBrid in the U.S. We have seen NexoBrid help burn patients worldwide and knowing that it may be soon available in the United States is very gratifying,” said Ofer Gonen, CEO of MediWound. “We thank both Vericel and BARDA for their leadership and commitment to this important program.”

The BLA re-submission adds to the set of manufacturing data, preclinical and clinical studies previously submitted. These include extensive scrutiny of the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints with a comparable safety profile to the standard of care. NexoBrid is approved in the European Union and other international markets. It has been designated as an orphan biologic drug in the United States, European Union, and other international markets. NexoBrid is currently an investigational product in the United States. Vericel Corporation (NASDAQ: VCEL) holds an exclusive license for North American commercial rights to NexoBrid.

NexoBrid development has been supported in part with federal funding from U.S. Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract numbers HHSO100201500035C and HHSO100201800023C.

Contract number HHSO100201500035C provides funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

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