Amryt's Wings Clipped By Delay For Butterfly Skin Drug Decision
FDA Puts Back Filsuvez PDUFA Date To End Of February
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.
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The Irish drugmaker will have three approved commercial products for rare diseases – Mycapssa, Lojuxta and Myalept – with a potential fourth therapy on the way now Filsuvez has been filed for butterfly skin.
With two revenue-generating products already on the market and Phase III data pending on Filsuvez for epidermolysis bullosa, CEO Joe Wiley has told Scrip that a US listing will give Amryt more visibility and credibility when it comes to future licensing and acquisition possibilities.
The London-based biotech is hoping to turn the dream of liver organ transplant without the need for lifelong immunosuppression into reality.