Filsuvez® (Birch Triterpenes) Topical Gel.

Abstract

Filsuvez^® (birch triterpenes) topical gel received approval in 2023 for the treatment of epidermolysis bullosa (EB) in pediatric patients (aged ≥6 months) and adults. It promotes wound healing by modulating inflammation, encouraging new tissue formation, and maintaining the skin barrier. In a randomized, double-blind, controlled, parallel-group, phase III trial (EASE, NCT03068780), 223 patients were randomly assigned to two groups: the first group received treatment with birch triterpenes topical gel (study gel, n = 109), and the second group received treatment with vehicle gel (n = 114). The study gel or vehicle gel was applied as a 1-mm layer to the affected wound surface once every 4 days for 90 days. The primary efficacy endpoint, defined as the first complete closure of the EB target wound by day 45, was achieved at a higher proportion in the study gel group (41.3% [45/109]), compared to the vehicle gel group (28.9% [33/114]). Application site reactions were reported in 7.3% (8/109) of patients in the study gel group and 6.1% (7/114) of patients in the vehicle gel group. It is recommended to apply as a 1-mm layer to the affected wound surface only.