Amryt (AMYT) Announces EU Approval of Filsuvez for Treatment of Dystrophic and Junctional EB

Amryt (Nasdaq: AMYT) is pleased to announce the European Commission (EC) 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, until now, there has been no approved treatment in any market.

The centralised marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez® in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.

The EC approval of Filsuvez® 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.

Dr Joe Wiley, CEO of Amryt Pharma, commented: “The EC approval of Filsuvez® in Europe is a major positive development for European patients who suffer from this debilitating condition. Filsuvez® will be our fourth commercial product for rare diseases. We have in place the team, financial flexibility and global infrastructure to bring it to market swiftly and to execute our significant growth plans. We are very excited to begin delivering Filsuvez® to treat European patients as soon as possible.”

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