Amryt Pharma new drug application won’t go through advisory committee

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Amryt Pharma PLC (NASDAQ:AMYT LON:AMYT) said the US Food and Drug Administration had confirmed its New Drug Application (NDA) for Oleogel-S10 does not require an Advisory Committee meeting.


Oleogel-S10 was developed to treat junctional and dystrophic epidermolysis bullosa (EB), where the skin is fragile to even the lightest touch.


It is a rare condition that affects young children and adults and there is currently no approved treatment.


An FDA advisory committee is an independent body that gives direction to the agency over a product applying for approval.


Usually, though not always, the FDA acts on the recommendation of an advisory panel.


Amryt said last week it expects a decision on Oleogel-S10 on or before 30 November 2021.


Shares in Amryt rose 0.6% to 171p.

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