The first medication specifically developed to treat Epidermolysis Bullosa (EB), has successfully completed a Phase 3 clinical trial.
Filsuvez © (Oleogel-S10, AP101) is a topical therapeutic gel developed by Amryt Pharma to treat wounds caused by EB, by aiding wound healing and reducing the pain caused by dressing changes.
Amryt has reported that Filsuvez © showed a 72% increase in the probability of wound closure compared to the control gel in Recessive Dystrophic Epidermolysis Bullosa (RDEB) patients.
The global incidence of EB stands at approximately one in 20,000, which implies that there are as many as 30,000 affected individuals in the US and over 500,000 worldwide.
The US regulatory submissions are underway with the Food and Drink Administration (FDA) and the European Medicines Agency (EMA) with a request for priority review by the end of the first quarter of 2021.
For more information, please see: https://www.irishexaminer.com/news/arid-40075325.html