Irish pharmaceutical company Amryt has taken an important step in bringing its treatment for a rare and distressing genetic skin condition to market.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of Filsuvez, which would be the first approved treatment in Europe for patients with epidermolysis bullosa (EB), also known as skin of butterfly. The condition, which affects both children and adults, sees their very fragile skin blister at the slightest touch.
The European regulator will now have 67 days to decide whether or not to support the recommendation of its committee of experts. The company said the UK Medicines and Health Products Regulatory Agency should grant clearance within the same time frame.
The recommendation for approval is based on data from the world’s largest trial in EB patients.
Amryt chief executive Dr Joe Wiley said the EMA committee’s support was “the most significant milestone in Amryt’s history and represents a major positive development for European patients suffering of this debilitating disease”.
“This is the culmination of years of hard work by the entire Amryt team. I would like to formally thank them, as well as all patients, caregivers and physicians for their commitment and efforts to bring us to this point,” Dr. Wiley said.