FDA Approves Filsuvez for Junctional and Dystrophic EB

The FDA has approved Chiesi’s Filsuvez for partial thickness wounds associated with dystrophic (DEB) and junctional epidermolysis bullosa (JEB) in patients 6 months and older. This follows approval of the treatment by the European Commission in June 2022, as well as NICE’s recommendation for use in the UK in August of this year.

Filsuvez is a topical gel that is applied at each dressing change.

This is exciting news for EB patients – Filsuvez is the first approved treatment for JEB and only the second for DEB. While not a cure, it has the potential to improve quality of life by closing wounds more quickly.

Chiesi added Filsuvez to its portfolio as part of its acquisition of Amryt Pharma in January this year.

Read the full Chiesi press release.