Irish-listed pharmaceutical company Amryt has completed discussions with the US Food and Drug Administration (FDA) as well as European Medicines Agency (EMA) on the design of a drug that will treat a skin disease known as Epidermolysis Bullosa.
EB is a rare genetic skin condition that makes the skin of those afflicted extremely delicate. Children suffering from the disease are known as “ Butterfly Children”.
The global market for treatment of the disease is thought to be around €1.3bn annually.
Amryt is on track to commence the phase 3 trial at the end of March and the company has agreed to conduct some further non-clinical studies in parallel with the phase three study.
“We are delighted to have reached this critical milestone in the development of Amryt,” said Amryt ceo Joe Wiley.
“Significantly, we now have agreement from the regulatory agencies in both the US and in Europe for a single phase 3 study, which we hope in due course will lead to approval in EB,” Mr Wiley added.