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US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA

 
• By Bridget Silverman

Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.

FILSUVEZ CONTAINS DRY EXTRACT OF BARK FROM BIRCH TREES (BETULAE CORTEX), A NATURAL SUBSTANCE THAT PROVIDES BETULIN AND RELATED TRITERPENE COMPOUNDS • Source: Alamy

Amryt Pharma plc is highlighting the potential for its Filsuvez (oleogel-S10) to become the first product approved for the rare genetic skin disorder Epidermolysis Bullosa, but the topical wound-healing agent could also join another small group of products: botanical drugs.

Filsuvez will be known generically in the US as birch triterpenes, reflecting its identity as a mixture, not a single substance, Amryt CEO Joe Wiley said in an interview with the Pink Sheet

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