Amryt completes rolling FDA submission for Oleogel-S10

Commercial-stage biopharmaceutical company Amryt Pharma has completed the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for ‘Oleogel-S10’, it announced on Wednesday, for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB).

The AIM-traded firm described EB as a “rare and distressing” genetic skin disorder affecting young children and adults, for which there was currently no approved treatment.

It said the submission included a request for priority review, which could expedite the process to six months following acceptance of the submission.

Previously, Oleogel-S10 was granted orphan, fast track and pediatric rare disease designation by the FDA.

The rolling submission of the NDA began on 29 June last year.

Amryt said that, based on FDA timelines, it was expecting to know whether priority review had been granted, and if the NDA was accepted for filing, in the second quarter of 2021.

It said the NDA was supported by data from the ‘EASE’ pivotal phase 3 trial in EB.

Amryt said in October that the EASE study met its primary endpoint of accelerated healing of the target wound by day 45 in patients treated with Oleogel-S10, when compared to the control gel.

“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 chief executive officer Dr Joe Wiley.

“Today’s news follows the recent validation of our marketing authorisation application for Oleogel-S10 with the European Medicines Agency.

“These developments also represent a potentially important advancement for patients and families living with this rare and distressing disorder.”

At 1005 BST, shares in Amryt Pharma were 0.05% lower at 205.89p.