Amryt Secures UK Regulatory Nod And Orphan Disease Status For Skin Disorder Candidate

The Medical Healthcare & Products Regulatory Agency (MHRA) has granted Marketing Authorisation Approval (MAA) and Orphan Disease Designation (ODD) for Amryt’s AMYT lead candidate Filsuvez for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older in Great Britain (GB).

The UK regulatory approval follows on from recent European Commission approval of Filsuvez.

Joe Wiley, Chief executive Officer, said,  "The approval of Filsuvez® by the MHRA is an important development for patients suffering from this debilitating condition and follows the approval of Filsuvez by the European Commission in June. We look forward to continuing our discussions with the reimbursement agencies across the UK and European Union to begin delivering Filsuvez® to treat patients as soon as possible and to also leverage our European approval to advance regulatory submissions in other jurisdictions such as the Middle East and LATAM."

Epidermolysis Bullosa (EB) is a rare and devastating group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development.

Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. 

Price Action : Amryt shares are trading around 2 percent higher at $7.98 on Thursday during pre-market session.