FDA Approves Birch Triterpenes Topical Gel for Epidermolysis Bullosa

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The FDA’s approval of Chiesi Global Rare Diseases’ topical gel marks the first approval for the variant of EB known as JEB.

The US Food and Drug Administration (FDA) approved the new topical gel by Chiesi Global Rare Diseases known as birch triterpenes topical gel (Filsuvez) for the treatment of 2 variants of epidermolysis bullosa (EB).1

The treatment, approved on December 19, is designed for the partial thickness wounds in seen in individuals aged 6 months and older with a diagnosis of Junctional Epidermolysis Bullosa (JEB) and with Dystrophic Epidermolysis Bullosa (DEB) also colloquially known as ‘Butterfly Disease.’

The birch triterpenes topical gel’s approval by the agency represents a major milestone in the EB treatment space, as it is the first FDA-sanctioned treatment for wounds that are known to be seen in JEB. JEB is known for being a rare and severe variant of EB that results in blistering from patients’ infancy.

“I want to thank Chiesi for their years of close collaboration with debra of America and their dedication and commitment to bringing a treatment option forward for those with dystrophic and junctional EB,” Brett Kopelan, the executive director of EB nonprofit group debra of America, said in a statement. “I also want to thank the patients who participated in the clinical trials to bring this therapeutic option to fruition.”

The new topical gel can be implemented through at-home administration, with its integration into existing treatment routines becoming a new possibility following the approval. The application of the gel is topical, and it is applied to wounds during each dressing change.

EB is an incapacitating and inherited skin disorder which is rare, but those facing the condition and its variants frequently have skin that becomes so fragile that even slight touches can result in pain and injury. This characterization is why the term ‘Butterfly Disease’ came into existence for those living with the condition.

The chronic condition is known to impact children, infants, and adults. The blistering and chronic wounds EB patients encounter re-occur and can result in severe pain and restrictions on patients’ mobility.

Those living with EB encounter daily challenges, including managing slow-healing wounds susceptible to infection and undergoing painful dressing changes.

The gene therapy treatment known as beremagene geperpavec or B-VEC (Vyjuvek) was approved in May of 2023 for treatment of DEB. B-VEC is a modified herpes simplex virus type 1 vector designed for patients with this particular variant of EB.2

Now that a new approval has been announced for JEB and DEB, the milestone decision represents a continuation of increasing EB treatment options for those with the rare and often debilitating skin disorder.

“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,” Giacomo Chiesi, head of Chiesi Global Rare Diseases, said in a statement.1


  1. Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ® (birch triterpenes) topical gel for the Treatment of Epidermolysis Bullosa. Chiesi Global Rare Diseases. December 19, 2023. Date accessed: December 19, 2023.
  2. Smith T. FDA Approves B-VEC Topical Gene Therapy for Dystrophic Epidermolysis Bullosa. HCPLive. May 19, 2023. Date accessed: December 19, 2023.