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MediWound Gets Scientific Advice From EMA Supporting Phase III Development Plan For EscharEx

July 03, 2023 — 07:32 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - MediWound Ltd. (MDWD) said it has received positive scientific advice from the Committee for Medicinal Products for Human Use within the European Medicines Agency related to the development plan for the company's Phase III study of EscharEx in the treatment of Venous Leg Ulcers and to the overall data required for subsequent potential marketing authorization submission and commercialization. The CHMP concurs with the overall design of the proposed study. Also, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval.

MediWound noted that EscharEx uses the same active pharmaceutical ingredient as the NexoBrid, which has been approved for debridement of thermal burns in the U.S. and Europe.

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