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]
 Chemical structure of betulin, one of the primary constituents of birch triterpenes | |
| Clinical data | |
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| Trade names | Filsuvez |
| Other names | Oleogel-S10 |
| AHFS/Drugs.com | Filsuvez |
| License data | |
| Routes of administration | Topical |
| ATC code |
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| Legal status | |
| Legal status | |
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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]
Medical uses edit
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]
Side effects edit
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]
Society and culture edit
Legal status edit
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]
References edit
- ^ "Filsuvez- birch triterpenes gel". DailyMed. 14 February 2024. Retrieved 3 March 2024.
- ^ a b c d e f g h i j k l "Filsuvez EPAR". European Medicines Agency (EMA). 13 April 2022. Archived from the original on 6 July 2022. Retrieved 6 July 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Filsuvez, common birch bark extract" (PDF). European Medicines Agency.
- ^ a b "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 19 December 2023. Archived from the original on 21 January 2023. Retrieved 22 December 2023.
- ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
- ^ a b c d "Filsuvez: Pending EC decision". European Medicines Agency (EMA). 22 April 2022. Archived from the original on 22 April 2022. Retrieved 22 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Filsuvez Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
- ^ "Chiesi Global Rare Diseases Receives FDA Approval for Filsuvez (birch triterpenes) topical gel for the Treatment of Epidermolysis Bullosa". Chiesi Global Rare Diseases (Press release). 19 December 2023. Archived from the original on 22 December 2023. Retrieved 22 December 2023.
