Irish biotech company Amryt Pharma has completed the rolling submission to US authorities of a New Drug Application (NDA) 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 rolling submission began on June 20th, 2020, and includes a request for priority review, which can expedite the review process to six months following acceptance of the NDA. It follows a successful outcome to phase III clinical trials in September and October, with a significant increase in the speed of wound healing. Oleogel-S10 is the first treatment to do this.
Amryt expects to receive notification if Priority Review has been granted and if the NDA has been accepted for filing in the second quarter of the year.
"Our NDA submission to the FDA marks another important milestone for Amryt as we progress our lead development candidate Oleogel-S10 with the regulatory authorities in both the US and Europe, " said Dr Joe Wiley, chief executive of Amryt Pharma.
“These developments also represent a potentially important advancement for patients and families living with this rare and distressing disorder. We will continue to work closely with the respective regulatory authorities with the hope of bringing Oleogel-S10 to patients as soon as possible.”