FDA Approves Filsuvez (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa
Chiesi Global Rare Diseases, a business unit of the Chiesi Group has announced that the U.S. Food and Drug Administration (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 epidermolysis bullosa (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 this year.
EB 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 administered at home, allowing for integration into existing treatment routines. Filsuvez is applied topically to the wound at each dressing change.
