Birch Triterpenes Topical Gel Gets FDA Approval for Treatment of Epidermolysis Bullosa

December 19, 2023

The approval provides the first-ever approved treatment for this EB variant.

Chiesi Global Rare Diseases announced today that the FDA had approved FILSUVEZ® (birch triterpenes) topical gel for the treatment of junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB) in patients 6 months or older. 

According to the manufacturer, this formulation is the first approved treatment for wounds associated with JEB (a rare, moderate-to-sever form of EB that begins in infancy). 

"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,” said Brett Kopelan, executive director of debra of America, in a news release. "Today marks an important milestone for those living with junctional EB, as FILSUVEZ is the first FDA approved treatment for this variant of the disease."

The drug was previously approved in June 2022 by the European Commission for the treatment of skin wounds in adults and children aged 6 months and older who had JEB and DEB. 

The EASE trial, which was the largest-ever global phase 3 trial conducted in patients with EB, looking at the proportion of patients in the study with complete wound closure with 45 days of treatment. The primary endpoint was achieved (P=0.013) with many favorable differences observed and reported. 

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