MediWound’s innovative drug, NexoBrid™, was approved in December 2012 by EMA via a centralized procedure and was granted orphan indication for removal of eschar (also known as debridement) in adults with deep partial- and full-thickness thermal burns .
NexoBrid is protected by patents as well as by EU & US orphan drug status that provides market exclusivity post-approval of 10 & 7 years, respectively.
Currently, MediWound initiated Phase III clinical study in the US and pediatric study.
For more information about NexoBrid™, please visit the product web site at: www.NexoBrid.com
NexoBrid™ is an efficacious, topically administered eschar removal agent that has been investigated in phase 2 and phase 3 clinical studies, by more than 100 leading burn specialists, in over 550 patients from 15 countries around the world:
- Successfully debride the wounds, much earlier than in the SOC patients (2.2 days vs. 8.7 days from injury)
- Significantly reduce the number of excisions performed (24.5% in NexoBrid vs. 70.0% in SOC, p<0.0001) and % wound area excised (13.1% in NexoBrid and 56.7% in SOC, p<0.0001)
- Significantly reduce the number of autografts performed (17.9% in NexoBrid vs. 34.1% in SOC, p=0.01) and % wound area autograft (8.4% in NexoBrid vs. 21.5% in SOC, p=0.005) in deep partial thickness wounds
NexoBrid™ is a new paradigm in treatment of burns with a significant advantages over current standard of care
- demonstrating ability to remove only the burn eschar post a single 4 hours topical application
- Unlike current topical treatments, NexoBrid™, has shown efficacy levels comparable to surgical debridement but without harming viable tissues
- Cost effective by providing earlier eschar removal and significantly minimizing the need for costly surgical procedures
NexoBrid™ mechanism of action is based on specific protolytic activity that degrades the eschar