Filsuvez®
FILSUVEZ®, developed by Chiesi Global Rare Diseases, is a prescription topical gel that supports wound healing in dystrophic (DEB) and junctional Epidermolysis Bullosa (JEB).
It is a topical gel based on an extract if birch bark to reduce skin inflammation and promote wound healing. It is the first EMA approved treatment for EB. Filsuvez (birch triterpenes) is approved as topical gel for the treatment of partial thickness wounds related to DEB and JEB in patients 6 months and older.
| Approved by | Date of Approval | Therapeutic Approach | Route of Administration | EB Subtype |
| EMA | June 2022 | Drug Therapy | Topical | DEB, JEB |
| FDA | December 2023 | Drug Therapy | Topical | DEB, JEB |
Please note that a marketing authorisation by a national or international regulatory authority (European Medicines Authority [EMA], Food and Drug Administration [FDA] etc.) does not indicate whether the therapy or medication is available in a particular country or is reimbursed by a health insurance fund.
Related links
Filsuvez® approved by FDA - EB-Research (eb-researchnetwork.org)
Filsuvez® Approval by EMA June 2022 - EB-Research (eb-researchnetwork.org)
Marketing authorisation for Filsuvez® recommended by EMA - EB-Research (eb-researchnetwork.org)
