(Reuters) -The U.S. Food and Drug Administration on Tuesday declined to approve MediWound Ltd’s topical burn treatment, NexoBrid, the company said.
The agency identified issues related to the chemistry, manufacturing and controls (CMC) section of the application and has requested additional information.
The FDA has, however, acknowledged the receipt of several CMC amendments, which were not reviewed for the decision.(https://refini.tv/2T9LviX)
The agency also called for an inspection of the drugmaker’s manufacturing facilities for NexoBrid in Israel and Taiwan before the potential approval. It was unable to inspect due to the COVID-19 related restrictions.
The complete response letter issued to the company also requested a safety update as part of its application resubmission.
NexoBrid, which removes burn tissue in patients with deep partial and full-thickness thermal burns, is currently approved in some countries.
Vericel Corp holds an exclusive license for North American commercial rights to NexoBrid.
(Reporting by Trisha Roy in Bengaluru; Editing by Arun Koyyur)
