A significant milestone in international EB research
The first drug for butterfly children approved in the EU
The drug developed by Amryt Pharma under the brand name Filsuvez® was approved by the European Medicines Agency (EMA) on 23 June 2022 for treating epidermolysis bullosa (EB) in the European Union. The therapeutic gel is based on an extract of birch bark and is effective for two (dystrophic and junctional) of the four types of EB. It is applied to the affected skin areas and is said to reduce skin inflammation and promote wound healing. The EB community is excited about the first-ever approved medicine for "butterfly children" worldwide.
As a first step, the Filsuvez gel will be available per prescription in Germany. We hope that the other EU countries will quickly follow.
Based on the largest clinical trial ever conducted in EB, the positive decision of the EMA could be made. In addition, several European national DEBRAs lobbied as patient organisation for the approval which was crucial for the whole process. It is not a cure yet but a big step to accelerate further drug development for EB patients.
We will keep you informed about the market entry of the Filsuvez gel.