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Trade names | Filsuvez |
Other names | Oleogel-S10 |
AHFS/Drugs.com | Filsuvez |
License data | |
Routes of administration | Topical |
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Birch triterpenes, sold under the brand name Filsuvez, is an extract of birch bark used as a topical medication for the treatment of epidermolysis bullosa.[2] The active ingredients are triterpenes extracted from the outer bark of silver birch (Betula pendula) and downy birch (Betula pubescens).[3]
The most common side effects include wound complications.[2] Other common side effects include skin reactions at the application site, wound infections, pruritus (itching), and hypersensitivity (allergic) reactions.[2]
Filsuvez was approved for medical use in the European Union in June 2022,[2] and in the United States in December 2023.[4]
Epidermolysis bullosa is an inherited disease of the skin that makes the skin very fragile and causes severe blistering and scarring.[2] Filsuvez is used in two types of epidermolysis bullosa, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, to treat partial-thickness skin wounds.[2] These are wounds where the upper layers of the skin have been damaged.[2]
Filsuvez is indicated for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in people aged six months of age and older.[2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]
The most common side effects include wound complications.[2] Other common side effects include skin reactions at the application site, wound infections, pruritus (itching), and hypersensitivity (allergic) reactions.[2]
In April 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Filsuvez, intended for the treatment of epidermolysis bullosa.[6] The applicant for this medicinal product is Amryt Pharmaceuticals DAC.[6] The active substance of Filsuvez is birch bark extract (as dry extract, refined) from Betula pendula Roth/Betula pubescens Ehrh. (equivalent to 0.5‑1.0 g birch bark), including 84‑95 mg triterpenes calculated as the sum of betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid.[6] It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound healing and closure.[6] Filsuvez was approved for medical use in the European Union in June 2022,[2][7] and in the United States in December 2023.[8][4]