Amryt Pharma PLC (NASDAQ:AMYT; AIM:AMYT) was granted a priority review of its new drug application for Oleogel-S10 by the US Food & Drug Administration with a decision expected on or before November 30.
The watchdog's fast-track has shortened the regulatory timeline from 10 months to six.
Oleogel-S10 was developed to treat junctional and dystrophic epidermolysis bullosa, 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.
Chief executive Joe Wiley said confirmation of the November 30 PDUFA date – the deadline for an FDA decision – kept Amryt on track for approval for the breakthrough new treatment by the year-end.
“If approved, Oleogel-S10 could potentially be an important treatment option for patients suffering from EB, a serious and debilitating disease for which there are currently no approved treatments and our launch plans for Oleogel-S10 are well advanced,” he added.