News

Filsuvez Gets Marketing Nod for DEB and JEB in Great Britain

Filsuvez (Oleogel-S10) has been approved in Great Britain — England, Scotland and Wales — for treating wounds associated with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) in patients ages 6 months and older. In addition to granting marketing authorization, Britain’s Medical Healthcare and Products Regulatory Agency (MHRA)…

Gene Therapy Gel Vyjuvek Granted FDA Priority Review for DEB

Krystal Biotech’s gene therapy gel Vyjuvek (beremagene geperpavec) for dystrophic epidermolysis bullosa (DEB) has been granted priority review by the U.S. Food and Drug Administration (FDA). Priority review status is expected to shorten the review process for applications to six months from the standard 10 months. A decision…

Metabolites Linked to Nourishment, Inflammation Altered in RDEB

Patients with recessive dystrophic epidermolysis bullosa (RDEB) had distinct blood metabolic profiles compared with healthy people, a study showed. The most significantly altered molecules were amino acids — the building blocks of proteins — most of which were at lower levels in RDEB patients and correlated with disease severity.

Hsp70 Autoantibodies Elevated in EBA, May Contribute to Disease

Self-reactive antibodies against the stress-induced heat shock protein 70 (Hsp70) were higher in the blood of patients with epidermolysis bullosa acquisita (EBA), a study found. In a corresponding mouse model, the researchers observed the autoantibodies contributed to a worse disease course, likely through the mediation of inflammatory pathways. “This…

Two New COL7A1 Mutations Identified in Boy With DEB

Two new mutations in the COL7A1 gene, one inherited from each parent, were identified as the cause of recessive dystrophic epidermolysis bullosa (DEB) in a 10-year-old boy, a case study reported. Further functional analyses suggested that each mutation had only mild effects — supported by the fact that his…

Filsuvez Significantly Reduces Wounds After 15 Months in Trial

People with dystrophic epidermolysis bullosa (DEB) saw the total surface of their wounds significantly reduced after being treated with Filsuvez (Oleogel-S10) for more than a year, new data from the EASE clinical trial show. After 15 months, these patients experienced sustained reductions of 53%, on average, in wound…

Filsuvez Gel Becomes 1st Therapy Approved in EU for EB Wounds

The European Commission has approved Amryt Pharma’s Filsuvez (Oleogel-S10) for the treatment of skin wounds in adults and children, ages 6 months and older, with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB). The decision makes Filsuvez, a topical gel, the first-ever therapy approved for EB wounds.