- April 2022
A topical gel containing birch bark extract as an active ingredient--Filsuvez (Oleogel-S10)--has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use.
Filsuvez would be shown to promote EB partial-thickness wound healing through modulation of inflammation mediators and stimulation of keratinocyte differentiation and migration.
The recommended indication for Filsuvez, currently designated as an orphan drug, is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients 6 months of age and older.
In February 2022, the U.S. Food and Drug Administration (FDA) refused to approve the company's new drug application to which it requested to submit further evidence of efficacy for Oleogel-S10 in EB.