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