Amryt Pharma has secured European Commission approval for its Filsuvez product for the treatment of dystrophic and junctional Epidermolysis Bullosa (EB) in patients six months and older.

EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market.

Flsuvez will be the first and only approved treatment for EB patients.

Amryt, which focuses on the development and commercialisation of treatments for orphan and rare diseases patients, has estimated that the global market opportunity for EB to be over $1 billion.

It said the centralised marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.

The authorisation of Filsuvez in the EU also provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.

Dr Joe Wiley, CEO of Amryt Pharma, said the EC approval in Europe is a major positive development for European patients who suffer from this debilitating condition.

"Filsuvez will be our fourth commercial product for rare diseases. We have in place the team, financial flexibility and global infrastructure to bring it to market swiftly and to execute our significant growth plans," Dr Wiley said.