MediWound shares tumble as FDA declines to approve treatment for burns

(Reuters) – The U.S. drug regulator on Tuesday declined to approve MediWound Ltd’s (MDWD.O) topical burn treatment, NexoBrid, the company said, sending its shares tumbling nearly 32% in early trading.

The Food and Drug Administration 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)

Shares of its partner, Vericel Corp (VCEL.O), which will sell NexoBrid in North America, also fell nearly 15%.

NexoBrid’s development is funded by the U.S. Biomedical Advanced Research and Development Authority (BARDA), including the ongoing expanded access protocol in the United States, allowing for the clinical use of NexoBrid during FDA’s review.

In July 2017, BARDA said it was providing up to $132 million funding to MediWound for NexoBrid. The contract served to advance the development and manufacturing as well as procurement of NexoBrid as a medical countermeasure for preparedness for mass casualty events.(https://bit.ly/35XEoNl)

NexoBrid, which removes burn tissue in patients with deep partial and full-thickness thermal burns, is approved in some countries. Eschar removal is a critical first step in the treatment of severe burns, which leads to about 100,000 patient hospitalization every year in the United States and Europe.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

“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,” the company said.

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 MediWound also requested a safety update as part of its application resubmission.

Reporting by Trisha Roy in Bengaluru; Editing by Arun Koyyur

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declined-approve-mediwound-treatment-burns-2021-06-29