MDWD - MediWound refiling for NexoBrid to treat severe thermal burns gets FDA review

• The U.S. Food and Drug Administration (FDA) accepted for review MediWound's ( NASDAQ: MDWD ) re-submitted biologics license application (BLA) seeking approval of NexoBrid for eschar (dead tissue) removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.
• The FDA is expected to make a decision by Jan. 1, 2023.
• MediWound said the the BLA re-filing adds to manufacturing data, preclinical and clinical studies — including a U.S. phase 3 study — previously submitted.
• Vericel ( NASDAQ: VCEL ) holds an exclusive license for North American commercial rights to NexoBrid, according to MediWound.
• MediWound noted that 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.

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