Marketing authorisation for Filsuvez® recommended by EMA

On 22 April, Amryt Pharma announced a remarkable milestone for EB patients. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) announced a recommendation for the approval of the Filsuvez® gel. The therapeutic ointment would be the first approved treatment for EB sufferers in Europe. 

The worldwide EB community is now waiting for the final approval decision, which is expected from the European Commission in the next 67 days. The Gel will be approved for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.  The centralised marketing authorisation would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.  The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is expected to grant authorisation within the same time period.

Jimmy Fearon, CEO of Debra Ireland and Board Member of Debra International, commented: “Today’s news is welcome and is extremely important to the many patients and their families that battle this terrible disease on a daily basis and have significant unmet medical needs.  A big thanks to the Amryt team, this is good news for our underserved families.”

The EASE trial (NCT03068780) was the largest ever global Phase 3 trial conducted in patients with EB, performed across 58 sites in 28 countries. It comprises a 3-month double-blind randomised controlled phase followed by a 24-month open-label, single-arm phase. Patients with dystrophic and junctional EB target wounds of between 10 and 50cm2 in size that were present for > 21 days and < 9 months were randomized in the double-blind phase to study treatment in a 1:1 ratio and wound dressings applied according to standard of care.  223 patients were enrolled into the trial including 156 pediatric patients.  Of those that completed the double-blind phase, 100% entered the open label safety follow up phase.

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