CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB

DUBLIN, Ireland, and Boston MA, April 22, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce 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® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.  EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

Based on this CHMP recommendation a decision by the European Commission (EC) is expected on the Filsuvez® application within 67 days.  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.

The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

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