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Amryt's Wings Clipped By Delay For Butterfly Skin Drug Decision

FDA Puts Back Filsuvez PDUFA Date To End Of February

 
• By Kevin Grogan

The Irish firm needs to give regulators in the US more information on its epidermolysis bullosa therapy but is confident of address those requests from its "existing data within the time periods required," according to CEO Joe Wiley.

Butterflies
An EB patient’s skin can be as fragile as butterfly wings • Source: Shutterstock

Amryt Pharma's hopes of getting a thumbs-up for Filsuvez by the end of the year have hit a bit of a bump with the news that US regulators have delayed a review of the Irish firm's butterfly skin therapy by three months.

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