Irish pharma company Amryt has taken a significant step to bringing its treatment for a rare and distressing genetic skin disorder to market.
The European Medicines Agency's committee for medical products for human use has recommended approval for Filsuvez, which would be the first treatment approved in Europe for patients with epidermolysis bullosa (EB), known also as butterfly skin. The condition, which affects children and adults, sees their very fragile skin blister at the slightest touch.
The European regulator will now have 67 days to decide whether to back the recommendation of its expert committee. The company said the UK’s Medicines and Healthcare products Regulatory Agency is expected to grant authorisation within the same time period.
The recommendation for approval comes on the back of data from the largest global trial conducted in EB patients.
Amryt chief executive Dr Joe Wiley said the backing of the EMA committee was "the most significant milestone in Amryt's history and represents a major positive development for European patients that suffer from this debilitating condition".
“This is the culmination of years of hard work from all the Amryt team. I’d like to formally thank both them and all the patients, care givers and physicians for their commitment and efforts in getting us to this point,” Dr Wiley said.