FDA Accepts MediWound's Refiling For Severe Thermal Burns Therapy For Review

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s MDWD recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

The regulatory agency has assigned a target action date of January 1, 2023.

The re-submission includes data from 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.

Ofer Gonen, CEO, commented: "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. We thank both Vericel and BARDA for their leadership and commitment to this important program."

Vericel Corporation VCEL holds an exclusive license for North American commercial rights to NexoBrid.

NexoBrid is approved in the European Union and designated as an orphan biologic drug in the United States, European Union and other international markets.

Price Action : MediWound shares are trading around 2 percent higher at $1.69 on Wednesday at the time of publication.