Amryt Faces Delay in Approval of EB Therapy in Europe

The European Medicines Agency notified Amryt Pharma that it plans to seek external independent Epidermolysis Bullosa expert advice on the assessment of Oleogel-S10, the company’s experimental therapy for the treatment of the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa, a rare genetic skin disorder. 

Photo: Joe Wiley, CEO of Amryt Pharma

Amryt said the EMA review process for Oleogel-S10 in EB is going and that it has responded to outstanding questions. The EMA has proposed that an Ad-Hoc Expert Group, comprised of both epidermolysis bullosa (EB) clinical experts and patients with EB, be consulted to provide external and independent EB specific advice.  The Committee for Medicinal Products for Human Use opinion is now anticipated in March 2022.

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. Patients with severe forms of EB suffer from severe, chronic blistering, ulceration and scarring of the skin, mutilating scarring of the hands and feet, joint contractures, strictures of the esophagus and mucous membranes, a high risk of developing aggressive squamous cell carcinomas, infections, and risk of premature death.  The global market opportunity for EB is estimated by the company to be in excess of $1.0 billion.

Amryt’s lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB. It is an herbal medicine product that contains triterpenes from birch bark. This sterile gel is being developed to speed up healing of skin wounds in adults and children with severe subtypes of EB. Amryt is using the brand name Filsuvez for Oleogel-S10. The product does not currently have regulatory approval to treat EB and is under review by the FDA and EMA.

“We welcome the input from independent EB physicians and importantly the voice of EB patients, via the Ad-Hoc Expert Group to assist the EMA progress its regulatory assessment of Oleogel-S10,” said Joe Wiley, CEO of Amryt Pharma. “If approved, we are confident in the potential for Oleogel-S10 to be an effective therapy for patients suffering from this terrible condition and are ready to launch what will be the first to market novel therapy in EB.”

Author: Rare Daily Staff