FDA approval for Filsuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa- Chiesi Global Rare Diseases.
Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced that the FDA approved 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. Filsuvez joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of 2023.
Epidermolysis Bullosa is a debilitating inherited skin disease that causes a person’s skin to be so fragile it can be injured just from touch. This rare, chronic, and distressing disorder affects infants, children and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility. Living with EB entails daily challenges to navigate, including slow-healing wounds at risk of infection and painful dressing changes.. Filsuvez is applied topically to the wound at each dressing change.
Filsuvez was previously approved in June 2022 by the European Commission for the treatment of skin wounds in adults and children, ages 6 months and older with both JEB and DEB.
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