Currently undergoing phase III clinical trials, the cream is being developed to treat Epidermolysis Bullosa (EB), a condition which occurs prominently in children and makes skin fragile to even the faintest touch.
It is chronic, potentially disfiguring and in some cases fatal. There are around 500,000 people living with EB worldwide and there are currently no approved treatments.
The FDA designation means if a new drug application for AP101 is approved, Amryt will be eligible to receive a priority review voucher that can be used, sold or transferred.
Chief executive Joe Wiley said the US regulator’s decision “recognises the rare and serious nature of EB and its impact on the lives of children suffering this condition”.
“With the interim efficacy readout for our phase III trial of AP101 in EB due later this year, we look forward to continuing to demonstrate progress with our lead development asset," he added.
The read-out of top-line data from the completed study is expected in the second quarter of next year.