Benzinga | Jun 29, 2021 08:47AM EDT

Vericel, MediWound Report That FDA Has Determined Application For MexoBrid Cannot Be Approved In Its Present Form

MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid(r) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.



The FDA communicated 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 FDA acknowledged receipt of several CMC amendments, submitted in response the CMC information requests, which were not reviewed for this action.

The FDA also stated 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 FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), 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.

"While we are disappointed that the FDA has issued a CRL for NexoBrid, we remain confident in the strength of our clinical data and in the depth of our development program," said Sharon Malka, Chief Executive Officer of MediWound. "We remain committed to working collaboratively with the Agency, as well as BARDA, to identify the most expeditious pathway toward a potential approval for this important therapy. We believe that, upon approval, NexoBrid will benefit severe burn victims in routine care and serve as a critical medical countermeasure in case of a U.S. mass casualty incident."

NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA), including the ongoing expanded access protocol (NEXT) 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.