AMYT - Amryt's Filsuvez gets approval in EU to treat rare skin disorder
- The European Commission (EC) approved Amryt's ( NASDAQ: AMYT ) Filsuvez to treat partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.
- EB is a rare disease in which the skin becomes fragile and can tear or blister from minor injury/rubbing.
- Filsuvez will be the first and only approved therapy for patients EB, the Dublin-based company said in a June 23 press release.
- The approval was backed by data from a phase 3 trial called EASE which included 58 sites in 28 countries.
- The company noted that 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.
- A day ago, Krystal Biotech ( KRYS ) filed for U.S. approval of its topical gene therapy B-VEC to treat patients with dystrophic EB.
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Amryt's Filsuvez gets approval in EU to treat rare skin disorder