FILSUVEZ Chiesi Australia Pty Ltd
Product name
FILSUVEZ
Sponsor
Accepted date
Apr-2025
Active ingredients
birch bark dry extract (84-95 per cent) triterpenes
Proposed indication
FILSUVEZ (Birch bark dry extract, 84-95% triterpenes) is for the treatment of wounds associated with epidermolysis bullosa in patients 6 months and older. Epidermolysis bullosa refers to a group of disorders caused by a faulty gene that affects proteins that hold skin layers together, causing skin to wound easily.
Application type
A (new medicine)
Publication date
Apr-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.