Amryt Pharma’s Filsuvez®, the first EB-specific treatment designed to heal partial thickness wounds in Dystrophic and Junctional EB in patients 6 months and older, has been approved by the European Commission (EC) for use in the EU. This means that the treatment has been declared safe for use in humans within the EU.
This is a fantastic step forward towards making this treatment available to the EB community in Ireland. The next step for Amryt Pharma is to submit an application to the National Centre for Pharmacoeconomics (NCPE) who will advise the HSE on whether they believe the treatment is good value for money. The HSE will consider their recommendation and make the final decision about whether they will fund this treatment. This process will take a number of years.

DEBRA Ireland will be advocating for this treatment to be funded by the HSE to ensure it is available here as soon as possible, however this can be a lengthy process.

For more information on the approval:
Amryt Pharma Press Release

For more information on Amryt Pharma’s Filsuvez®:

Phase 3 Clinical Trial Success
First ever successful Phase 3 Clinical Study
Amryt Pharma

We will keep you updated on the progress of this treatment and any actions we are taking. If you would like to discuss EB research further, please contact: [email protected]