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Vericel and MediWound Receive the US FDA’s Approval of NexoBrid for Severe Thermal Burns

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Vericel and MediWound Receive the US FDA’s Approval of NexoBrid for Severe Thermal Burns

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  • The US FDA has approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns with expected availability in Q2’23 in the US
  • The approval was based on the pre-clinical & clinical studies, incl. the P-III study (DETECT) of NexoBrid. The study met its 1EPs of incidence of ≥95% eschar removal over gel vehicle & 2EPs incl. shorter time to eschar removal, lower incidence of surgical eschar removal, non-inferiority in time to >95% wound closure was achieved
  • NexoBrid was approved in 43 countries, incl. the EU, Japan, India & other international markets. Under the collaboration with Vericel, MediWound will receive a $7.5M milestones & Vericel holds an exclusive license to commercialize NexoBrid in North America

 Ref: MediWound | Image: MediWound

Related News:- Mallinckrodt Reports Results of StrataGraft in P-III STRATA2016 Study for Thermal Burns

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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