A European Medicines Agency (EMA) committee has recommended the approval of the use of Amryt Pharma's Filsuvez in the EU for the treatment of partial thickness wounds associated with Epidermolysis Bullosa (EB) in those aged over six months.
The condition is a rare genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
Patients suffer from severe, chronic blistering, ulceration and scarring of the skin, mutilating scarring of the hands and fee and are at a high risk of developing infections and other life threatening complications.
The recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) paves the way for a formal decision by the European Commission on an application for marketing authorisation.
It would be valid in all EU member states, as well as Iceland, Liechtenstein and Norway.
"The CHMP recommendation for approval of Filsuvez® in Europe is the most significant milestone in Amryt’s history and represents a major positive development for European patients that suffer from this debilitating condition," said Dr Joe Wiley, CEO of Amryt Pharma.
"This is the culmination of years of hard work from all the Amryt team."
Today’s decision follows the submission to the committee of data from the largest ever global trial conducted in patients with EB, which took place across 58 sites in 28 countries.
The UK medicines regulator is also now expected to grant authorisation for the drug within the same time period as the EU Commission has to make its decision.
"Today’s news is welcome and is extremely important to the many patients and their families that battle this terrible disease on a daily basis and have significant unmet medical needs," said Jimmy Fearon, chief executive of EB support group Debra Ireland and Board Member of Debra International.
If approved, Filsuvez will be the fourth commercial product of the Dublin and Boston based firm.
