Amryt provides an update on FDA review process for Oleogel-S10 a treatment for epidermolysis bullosa.

The FDA extended the Prescription Drug User Fee Act (“PDUFA”) goal date to allow time to review additional analyses of data previously submitted by Amryt. The submission of this additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the PDUFA goal date by three months to February 28, 2022. This is a standard review extension period to allow the FDA additional time to review information already submitted by Amryt. At the same time, the FDA also issued a new Information Request regarding existing study data in order to continue the FDA’s evaluation of Amryt’s NDA.

In June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The PDUFA goal date extension has no impact on the priority review status of Oleogel-S10. The European Medicines Agency (“EMA”) review process for Oleogel-S10 in EB is ongoing and Amryt is in the process of responding to the remaining Major Objections in the List of Outstanding Issues sent by the EMA. The Committee for Medicinal Products for Human Use (“CHMP”) opinion is now expected in January 2022.