Chiesi Receives the US FDA's Approval for Filsuvez as a Treatment for Epidermolysis Bullosa (EB)
Shots:
- Filsuvez was evaluated vs control gel in a P-III (EASE) clinical trial in patients (n=223) with EB (wound size between 10-50cm2) across 58 sites in 28 countries. The 1EP of the study incl. efficacy of Filsuvez vs control gel
- The study met both its 1EP & 2EP by depicting statistically significant results along with favorable differences between Filsuvez and control gel. Moreover, Chiesi received the rights to Filsuvez through its acquisition of Amryt Pharma in Jan 2023
- Filsuvez is a topical gel used for the treatment of adults and children aged 6mos.or older with EB & has been approved by the EMA in Jun 2022 for both JEB & DEB
Ref: Chiesi | Image: Chiesi
Related News:- Amryt Receives CHMP Positive Opinion of Filsuvez for the Treatment of Dystrophic and Junctional EB
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
