Amryt Pharma PLC (AIM:AMYT, NASDAQ:AMYT) said its forecasts for 2021 revenues would be unaffected after the US Food and Drug Administration made a three-month extension to the review period for the new drug application (NDA) for its Oleogel-S10 for the treatment of junctional and dystrophic epidermolysis bullosa.
This is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
The FDA extended the date to the end of February 2022 to allow time to review additional analyses of data previously submitted by Amryt, the company said, with the additional information called for by the US regulator as part of what constitutes a major amendment to the NDA.
A new information request was also made by the FDA regarding existing study data in order to continue its evaluation of the NDA, which the regulator confirmed in June this year had been accepted and granted priority review.
The extension has no impact on the priority review status of Oleogel-S10, Amryt said.
European regulators are expected to receive an opinion from the Committee for Medicinal Products for Human Use (CHMP) in January 2022.
Amryt chief executive Joe Wiley said: “We are well positioned to address these regulatory requests from our existing data within the time periods required and we look forward to our continued productive discussions as the regulatory agencies complete their review. If approved, we are confident in the potential for Oleogel-S10 to be an effective therapy for patients suffering from this terrible condition and are ready to launch what will be the first to market novel therapy in EB.”
The company said its previously issued revenue guidance for FY 2021 in the range of US$220mln-US$225mln, which represents growth of 20%-23% on FY 2020, is unaffected by the new regulatory timelines.