The FDA approved Filsuvez (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients aged six months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB).
According to the Phase 3 clinical trial, Filsuvez was well tolerated and met the primary endpoint with statistical significance, with 41.3% of patients achieving first complete target wound closure within 45 days.
Epidermolysis Bullosa (EB) is a debilitating inherited skin disorder that causes a person’s skin to be so fragile it can be injured just from touch. This rare, chronic, and distressing disease affects infants, children, and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility.
Filsuvez was earlier approved in June 2022 by the European Commission for the treatment and management of skin wounds in adults and children, ages 6 months and older with both JEB and DEB.
On December 19, 2023, the US 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). It is the first approved therapeutic drug for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy.
About Epidermolysis Bullosa (EB):
Epidermolysis Bullosa (EB) is a rare, chronic, and devastating group of debilitating hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister occurrence. Patients with severe EB suffer from severe, chronic blistering, ulceration, and scarring of the skin, joint contractures, mutilating scarring of the hands and feet, strictures of the oesophagus and mucous membranes, a high risk of having an aggressive form of squamous cell carcinomas, infections and probability of premature death. Living with this rare disorder entails daily challenges to navigate, including slow-healing wounds with the probability of infection and painful dressing changes.
About Filsuvez topical gel:
Filsuvez (birch triterpenes) is a new topical gel for adults and children aged six months or older with EB (Epidermolysis Bullosa). It contains a dry extract from 2 species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, erythrodiol, betulinic acid, lupeol, and oleanolic acid. Filsuvez is supplied as a gel that needs to be applied to the wound surface at a thickness of around 1 mm and covered by a wound dressing. The drug can also be applied directly to the wound dressing. It is administered at home, enabling integration into existing treatment routines.
Important Safety Information:
Warnings & Precautions: Local hypersensitivity and skin reactions have been noted in patients treated with Filsuvez, including urticaria and dermatitis. In case signs or symptoms of hypersensitivity develop, stop using it immediately and initiate relevant therapy.
Adverse Reactions: The most commonly noted adverse reaction in clinical trials was pruritis and pain at the wound application site
References:
https://www.drugs.com/history/filsuvez.html
