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Birch triterpenes

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Birch triterpenes

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. The active ingredients are triterpenes extracted from the outer bark of silver birch (Betula pendula) and downy birch (Betula pubescens).

The most common side effects include wound complications such as skin reactions at the application site, infections, pruritus (itching), and hypersensitivity.

Birch triterpenes was approved for medical use in the European Union in June 2022, and in the United States in December 2023.

Epidermolysis bullosa is an inherited disease of the skin that makes the skin very fragile and causes severe blistering and scarring. Birch triterpenes is used in two types of epidermolysis bullosa, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, to treat partial-thickness skin wounds. These are wounds where the upper layers of the skin have been damaged.

Birch triterpenes 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. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

The most common side effects include wound complications. Other common side effects include skin reactions at the application site, wound infections, pruritus (itching), and hypersensitivity (allergic) reactions.

The active substance of birch triterpenes 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. The mechanism of action of birch triterpenes in the treatment of wounds associated with epidermolysis bullosa is unknown. It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound healing and closure.

The pharmacodynamics of birch triterpenes are unknown.

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