MDWD - FDA declines to approve MediWound's NexoBrid eschar removal treatment

MediWound (MDWD) announces that the U.S. FDA has declined to approve the company's NexoBrid treatment for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.The health regulator said that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form.The FDA identified issues related to the Chemistry, Manufacturing and Controls (“CMC”) section of the BLA and requested additional CMC information.The agency also requested to provide a safety update as part of its BLA resubmission, although there were no safety issues raised in the CRL."We remain committed to working collaboratively with the Agency, as well as BARDA, to identify the most expeditious pathway toward a potential approval...," CEO Sharon Malka said.

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FDA declines to approve MediWound's NexoBrid eschar removal treatment