We are delighted to share that the first ever EB specific treatment is one step closer to bedside in Europe. 

Amryt Pharma’s Filsuvez® for the treatment of Dystrophic EB (DEB) and Junctional EB (JEB) received a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommending the product for approval in the EU for the treatment of EB wounds (partial thickness wounds association with DEB and JEB) in patients 6 months and older. The CHMP has spent the last year reviewing the safety and efficacy data for Filsuvez®.

The European Commission now has 67 days to decide whether to grant the product market authorisation in Europe. If approved, the company can then approach national payers to seek reimbursement for this treatment. The national payer in Ireland is the National Centre for Pharmacoecomomics (NCPE). 

As shown below, this welcome news is the first step in a process that must be followed to make a new medicine available in Ireland. We will keep you updated on the progress of this treatment.

For more information:
Amryt Pharma press release
Irish Times

For more information on Amryt Pharma’s Filsuvez® see links below

https://debraireland.org/news-research/phase-3-clinical-trial-success-for-wound-healing-gel/

https://debraireland.org/eb-news/first-ever-successful-phase-iii-clinical-study-for-a-potential-wound-healing-product-for-eb/

https://amrytpharma.com/

If you would like discuss EB research further, please contact us on [email protected]