Researcher holding slide under microscope

In what could be a major breakthrough in the treatment of epidermolysis bullosa (EB), Amryt Pharma, a global biopharmaceutical company that focusses on acquiring, developing and commercialising novel treatments for rare diseases, has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Filsuvez® within the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients 6 months and older.

Filsuvez® is a gel applied to the skin that contains birch bark extract, which is rich in a compound called Betulin. Research suggests that Betulin can activate skin cells and regulate the inflammatory response involved in wound healing. The benefit of Filsuvez is its ability to promote healing of partial thickness wounds.

Based on the recommendation from the CHMP, a final decision from the European Commission (EC) is expected by early July and if approved, the centralised marketing authorisation for Filsuvez® would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. In the UK it is expected that the Medicines and Healthcare products Regulatory Agency (MHRA) will grant authorisation within the same time period.

This is very positive news and a step closer to getting the first approved treatment for EB. DEBRA UK would like to thank Amryt for their hard work and commitment to finding a treatment which could help many people suffering with this debilitating skin condition, and we look forward to the update from the EC in July.

To read the full update from Amryt, please click here.