Mediwound Ltd (NASDAQ: MDWD) today announced it obtained a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning the Biologics License Application (BLA). The company was looking for endorsement of NexoBrid® for eschar removal (debridement) in grownups with profound partial-thickness and full-thickness thermal burns.
FDA communicates it cannot accept the request in its current form
The FDA conveyed that it had finished its appraisal of the BLA, as revised, and has established that the submission cannot be accepted in its present form. The FDA recognized matters connected to the Chemistry, Manufacturing, and Controls segment of the BLA and added CMC information. The FDA accepted delivery of several CMC alterations, acquiesced in rejoinder the CMC information requirements, which did not go over for this action.
The FDA also specified that examining NexoBrid’s engineering amenities in Israel and Taiwan is mandatory before the FDA can accept the BLA. Still, it could not conduct the obligatory reviews during the current appraisal cycle due to COVID-related travel limitations.
The FDA specified that it would endure monitoring the public health state and travel limitations and vigorously outline an approach for arranging unresolved reviews.
In addition, the CRL mentioned specific explanations recognized during good clinical practice (GCP) examinations related to the U.S. Phase 3 study (DETECT) and demanded the company to provide its views on the possible influence, if any, of these explanations on the effectiveness conclusions in the reading.
Company Remains Dedicated to Working with FDA Towards a Possible Sanction for this Significant Treatment
“While we are saddened that the FDA has allotted a CRL for NexoBrid, we persist to be self-assured in the forte of our scientific data and in the profundity of our development program,” said Sharon Malka, Chief Executive Officer of MediWound. “We continue dedicated to functioning collaboratively with the Agency, as well as BARDA, to recognize the speediest pathway toward a possible ratification for this important treatment. We trust that, upon authorization, NexoBrid will profit stark burn sufferers in mundane care and help as a perilous therapeutic countermeasure in case of a U.S. bulk loss event.”