Filsuvez® FAQs

Filsuvez® is a sterile gel containing birch bark extract that helps EB wounds to heal.

Filsuvez® is licensed for use by anyone older than 6 months with Dystrophic EB (DEB) or Junctional EB (JEB).

Filsuvez® gel helps EB wounds to heal.

Over 200 adults and children with Dystrophic, Junctional and Kindler EB were involved in a phase 3 clinical trial that produced the evidence that Filsuvez® gel helped wounds to close more quickly.

41% showed complete wound closure within 45 days compared to 29% using a placebo gel that did not contain the active ingredient. During the initial 90-day treatment period, 32% of participants given Filsuvez® required daily wound dressing changes compared to 50% of those using the placebo, and those treated with Filsuvez® reported reduced pain when dressings were changed. More recent trial data showed that the percentage of the body surface area that was wounded decreased on average by more than half for DEB patients after 15 months using Filsuvez®.

Yes. Filsuvez® is available on prescription now for patients aged 6 months+ with Junctional and Dystrophic EB in England, Wales, and Northern Ireland. Filsuvez® has also been approved by the Scottish Medicines Consortium and we expect it to be available on prescription through NHS Scotland following agreement between Chiesi, the pharmaceutical company who developed the drug, and the Scottish Government on the data collection requirements, this is expected by September 2024.

Filsuvez® received a marketing authorisation from the MHRA, valid in England, Scotland and Wales, in September 2022. The European Medicines Authority (EMA) authorised its use throughout the EU and in Northern Ireland in June 2022.  Application to the Food and Drug Administration (FDA) for marketing authorisation in the US was rejected in February 2022 as needing more evidence that it was effective in EB.

Filsuvez® can only be prescribed by the four specialist centres in the UK.

We have been working with NICE to ensure that the experience of our members is represented in their process for bringing this treatment to the UK, ensuring that NICE hears the DEBRA voice. DEBRA members will also be invited to become involved. If you are interested in our research opportunities for members, please complete our survey.

We’ll work with the specialist centres and EB nurses to ensure that those affected can access this treatment.

The way Filsuvez® gel works is not fully understood.

Laboratory studies suggest that the active ingredient may attract and promote the development of skin cells called keratinocytes as well as affecting the process of inflammation.

Please see the Filsuvez® patient information leaflet from the Electronic Medicines Compendium (EMC) enclosed with Filsuvez® gel for more detailed information on side effects.

Filsuvez® contains an extract from two species of birch tree bark consisting of naturally occurring substances known as triterpenes. These include betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid.

Please see the Filsuvez® patient information leaflet from the Electronic Medicines Compendium (EMC) enclosed with Filsuvez® gel for more detailed information.

Your doctor or nurse will let you know if treatment with Filsuvez® can be combined with your other medication.

Filsuvez® is a greasy, opalescent gel that may have a slightly yellowish colour.

Chiesi.

Filsuvez® has been licensed only to treat wounds in patients with DEB and JEB. People with EBS were not included in the clinical trial so no evidence exists that Filsuvez® would be beneficial. Please speak to your specialist doctor about which treatments are most suitable for your type of EB.

Please see the Filsuvez® patient information leaflet from the Electronic Medicines Compendium (EMC) enclosed with Filsuvez® gel for more detailed information.

Your doctor or nurse will let you know if treatment with Filsuvez® is suitable for you.