Irish biotech company Amryt Pharma has been granted a priority review of a new drug application for its treatment for a rare medical condition known as "butterfly skin".
The drug Oleogel-S10 – also referred to as Filsuvez – is a gel which is a first therapy for patients with epidermolysis bullosa (EB), a hereditary condition also known as butterfly skin disease where the skin blisters at the slightest contact.
The US Food and Drug Administration’s priority review can expedite the review process to six months following acceptance of the NDA, from the normal 10 months. The FDA has set a Prescription Drug User Fee Act target action date for the NDA of November 30th, putting it on track for potential approval later this year.
"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," said Joe Wiley, chief executive of Amryt Pharma.
Oleogel-S10 previously received fast track designation and rare paediatric disease designation from the FDA.
