Filsuvez (Birch bark dry extract - 84-95% triterpenes)
Filsuvez is approved for the treatment of partial-thickness wounds of the skin associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older. Filsuvez contains the active ingredient birch bark dry extract [84-95% triterpenes].
Filsuvez is a prescription topical gel that has been approved to treat partial-thickness (outermost layer) skin wounds caused by dystrophic or junctional epidermolysis bullosa (EB). It can be used in adults and children aged 6 months or older, who have these two distinct types of EB.
EB is a group of inherited conditions that cause the skin to be extremely fragile and prone to wounds.
People with EB have a gene mutation that affects proteins that hold skin layers together, causing the top layer of the skin or membrane to separate from the lower layer. As a result, people with EB can develop skin wounds, blistering and scarring in response to a minor injury from heat, rubbing or scratching. In severe cases, blisters can also form inside the body, such as the lining of the mouth or stomach (mucous membranes).
Filsuvez gel is a medicine which contains dry birch bark extract from birch trees. It contains natural substances called triterpenes, which help support the healing of skin wounds in people with dystrophic and junctional EB.
The exact way this medicine promotes wound healing is not fully understood. Filsuvez helps wounds heal by protecting the skin and supporting its natural repair process. It is thought to do this by encouraging the growth of skin cells in the damaged layers of skin, helping the wound fill in and gradually close. This can also help reduce pain and lower the risk of infection, which can be challenging to treat in people with EB.
The effectiveness and safety of Filsuvez were assessed in one main clinical study called the EASE study. It included 223 adults and children with inherited EB. The participants required treatment (dressings) on specific identified (targeted) partial-thickness wounds for a total of 90 days.
Key findings from clinical studies
- The number of study participants reporting complete closure of their target EB wound, within 45 days of commencing treatment, was higher in the Filsuvez treatment group (41.3%) compared to the control gel (non-medicine) group (28.9%).
- Over half (50.5%) of participants in the Filsuvez treatment group achieved first EB target wound closure at approximately 90 days.
- The most common reactions (affecting more than 1 in 10 people) of EB patients receiving Filsuvez treatments were wound complications. These included an increase in wound size, wound re-opening, pain and bleeding from the wound.
- Other common side effects (affecting 1 in 100 people) included skin reactions at the dressing site (rash, hives and eczema), infection, pain and itching.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Filsuvez and the medicine can be registered in Australia.
More detailed information on why the TGA approved Filsuvez will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Filsuvez can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Filsuvez can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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