Amryt Pharma new drug application won't go through advisory committee
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.
Story by ProactiveInvestors
Source: http://www.proactiveinvestors.com/companies/news/951569/amryt-pharma-new-drug-application-won-t-go-through-advisory-committee-951569.html
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