MediWound Ltd. said it received a Complete Response Letter from the U.S. Food and Drug Administration regarding the Biologics License Application seeking approval of NexoBrid for eschar removal, or debridement, in adults with deep partial-thickness and/or full-thickness thermal burns.
The company said the FDA communicated that it had completed its review of the BLA as amended, and has determined that the application can't be approved in its present form.
Vericel Corp., MediWound's development partner, holds an exclusive license for North American commercial rights to NexoBrid.
The FDA identified issues related to the Chemistry, Manufacturing and Controls section of the BLA and requested additional CMC information. The FDA acknowledged receipt of several CMC amendments, submitted in response the CMC information requests, which weren't reviewed for this action.
The FDA also said that an inspection of NexoBrid's manufacturing facilities in Israel and Taiwan are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to Covid-related travel restrictions.
The letter also cited certain observations identified during good clinical practice inspections related to the U.S. Phase 3 study, and requested the company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study. The FDA also requested to provide a safety update as part of its BLA resubmission, although there were no safety issues raised in the CRL.
NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the U.S., E.U. and other international markets.
Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority, including the ongoing expanded access protocol in the U.S., which allows for the continued clinical use of NexoBrid during FDA's review of the NexoBrid BLA. In addition, BARDA procured NexoBrid for the U.S. emergency stockpile as part of its mission to build national preparedness for public health emergencies.
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