FDA extends review process for Oleogel-S10

The US Food and Drug Administration has extended the review period for the New Drug Application (NDA) for Oleogel-S10 for the treatment of the cutaneous manifestations of junctional and dystrophic bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

The NDA was filed by Ireland headquartered rare diseases firm Amryt Pharma (AIM: AMYT) in March this year. The drug, trade named Filsuvez, is also under review with the European Medicines Agency. The news sent Amryt’s New York traded shares down more than 10% to $10.8 by close of trading on Tuesday.

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.