Amryt submits NDA to the FDA for Oleogel-S10
pharmafile | March 31, 2021 | News story | Research and Development | FDA
Amryt has today announced the rolling submission of a New Drug Application (NDA) to the FDA for Olegel-S10, potential treatment of cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB).
There are currently no approved treatments for EB, a rare genetic skin disorder that affects both young children and adults.
The NDA submission includes a request for priority review which can expedite the review process to six months, following acceptance of the NDA submission. Previously, Oleogel-S10 has been granted Orphan, Fast Track and Paediatric Rare Disease designation by the FDA.
Dr Joe Wiley, CEO of Amryt Pharma, 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. Today’s news follows the recent validation of our MAA for Oleogel-S10 with the EMA.
“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.”
Amryt’s submission of the NDA is supported by data from the EASE pivotal Phase III trial into EB, which met its primary endpoint of accelerated healing of the target wound by day 45 in patients treated, in October last year.
Based on FDA timelines, Amryt expects to receive notification if priority review has been granted and if the NDA has been accepted for filing, in Q2 of 2021.
There are three main types of EB, which are all caused by a gene mutation that causes skin to become more fragile. The disease makes skin prone to blistering, which can occur on the arms and legs, inside the mouth, on the hands, and soles of the feet. EB also causes skin to scar, sometimes with small white spots called milia, and the thickening of the skin and nails. It is estimated that EB occurs in around 1 in 50,000 live births.
Kat Jenkins
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