The U.S. FDA Approves FILSUVEZ topical gel for JEB and DEB
debra of America is thrilled to announce a groundbreaking milestone for the Epidermolysis Bullosa (EB) Community: The U.S. Food and Drug Administration (FDA) has granted approval for 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).
FILSUVEZ® is the FIRST approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy, and the SECOND approved treatment for those with DEB, following the approval of VYJUVEK™ in May 2023.
FILSUVEZ® offers the convenience of at-home administration, allowing for integration into existing treatment routines. It can be applied topically to the wound at each dressing change.
debra of America’s close partnership with Chiesi has been instrumental in the approval of FILSUVEZ®, underscoring the importance of the patient perspective in therapy development for EB.
"This approval is an important milestone in providing a new treatment for EB and would not have been possible without debra of America’s dedication, commitment, and participation in the clinical trial recruitment efforts," shares Giacomo Chiesi, Head of Global Rare Diseases at the Chiesi Group. "On behalf of Chiesi Global Rare Diseases*, I want to also express our heartfelt gratitude to you for your steadfast interactions with the FDA on behalf of the EB community and for playing such an important role in making this regulatory approval a reality."
“I am so excited to say that this is another hurdle cleared and milestone achieved for the EB Community,” Brett Kopelan, Executive Director at debra of America shares, “the entire team at debra can’t thank everyone at Chiesi enough for their hard work, dedication, and commitment to the EB Community by bringing FILSUVEZ® through to approval. We are now on the road to being able to treat EB more effectively, and to make the worst disease you’ve never heard of, chronic but livable, by making use of multiple therapeutic options in conjunction with each other.”
For more information, read the Chiesi press release.
Learn More about Filsuvez® and Other Approved Treatments for EB
