The U.S. Food and Drug Administration (FDA) approved FILSUVEZ (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB).
Chiesi Global Rare Diseases’ FILSUVEZ is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy.
FILSUVEZ joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January 2023.
FILSUVEZ was well tolerated and met the primary endpoint with statistical significance, with 41.3% of patients achieving first complete target wound closure within 45 days in the Phase 3 clinical trial.
The gel is administered at home and applied topically to the wound at each dressing change.
“We are grateful for the support of those living with EB and their dedicated caregivers which allowed us to reach this landmark FDA approval and proudly provide FILSUVEZ as a solution for wound care management,” says Giacomo Chiesi, Head of Chiesi Global Rare Diseases, in a news release.
Brett Kopelan, Executive Director, debra of America, adds, “The FDA’s decision to approve FILSUVEZ provides those living with EB a safe and effective treatment option for the most prominent and difficult symptom of EB, open wounds that may not heal.”
FILSUVEZ was approved in June 2022 by the European Commission for the treatment of skin wounds in adults and children, ages 6 months and older with both JEB and DEB.
