European approval for Amryt's Oleogel-S10 moves closer

Commercial-stage biopharmaceutical company Amryt Pharma announced the validation of its marketing authorisation application for ‘Oleogel-S10’ by the European Medicines Agency on Monday, for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa.

The AIM-traded firm described epidermolysis bullosa (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 European Medicines Agency (EMA) validation confirmed that the application was sufficiently complete to begin the formal review process.

The EMA review for Oleogel-S10 would be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use (CHMP) expected within 210 ‘active’ days, which excludes any pauses for the applicant to provide answers to questions from the committee.

Amryt said the marketing authorisation application (MAA) was supported by data from the EASE pivotal phase 3 trial in EB.

It announced 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.

“The validation of the Oleogel-S10 MAA marks another important milestone for Amryt as we progress our lead development candidate Oleogel-S10 with the regulatory authorities in both Europe and the US,” said chief executive officer Dr Joe Wiley.

“Today’s news also represents 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.”

At 0813 GMT, shares in Amryt Pharma were up 2.5% at 205p.