Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it hopes its gel designed to treat a rare skin disease will win fast-track approval from the US Food & Drug Administration after finishing the rolling completion process.
Its new drug application (NDA) for Oleogel-S10 could be reviewed in just six months under an expedited protocol that aims to bring through new products for rare ailments such as junctional and dystrophic epidermolysis bullosa (EB).
Amryt said it expects to receive notification if priority review has been granted and if the NDA has been accepted for filing in the second quarter.
The application is supported by data from its EASE phase III trial in EB.
Chief executive Dr Joe Wiley said: “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.”
Wednesday’s news follows the recent validation of Amryt’s market 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. We will continue to work closely with the respective regulatory authorities with the hope of bringing Oleogel-S10 to patients as soon as possible,” added Wiley.
Amryt also put out a statement announcing its support for World Lipodystrophy Day 2021 which takes place today.
Lipodystrophy is a debilitating ultra-rare disease characterized by the lack of subcutaneous fat. The inability to store fat under the skin causes fat to be stored in places such as the muscles and liver which leads to severe metabolic complications including insulin resistance, diabetes, dyslipidemia, heart disease, kidney disease, fatty liver disease and many others. Currently, there is no cure for lipodystrophy and only the secondary complications can be managed/treated. Lipodystrophy affects approximately one in one million people across the world.