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.[1][3] The active ingredients are triterpenes extracted from the outer bark of silver birch (Betula pendula) and downy birch (Betula pubescens).[4]
 Chemical structure of betulin, one of the primary constituents of birch triterpenes | |
| Clinical data | |
|---|---|
| Trade names | Filsuvez |
| Other names | Oleogel-S10 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624016 |
| License data | |
| Routes of administration | Topical |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
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The most common side effects include wound complications such as skin reactions at the application site, infections, pruritus (itching), and hypersensitivity.[3]
Birch triterpenes was approved for medical use in the European Union in June 2022,[3] and in the United States in December 2023.[5][6]
Medical uses
editEpidermolysis bullosa is an inherited disease of the skin that makes the skin very fragile and causes severe blistering and scarring.[3] Birch triterpenes is used in two types of epidermolysis bullosa, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, to treat partial-thickness skin wounds.[3] These are wounds where the upper layers of the skin have been damaged.[3]
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.[1][3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
Side effects
editThe most common side effects include wound complications.[3] Other common side effects include skin reactions at the application site, wound infections, pruritus (itching), and hypersensitivity (allergic) reactions.[3]
Pharmacology
editMechanism of action
editThe 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.[3] The mechanism of action of birch triterpenes in the treatment of wounds associated with epidermolysis bullosa is unknown.[1] It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound healing and closure.[3]
Pharmacodynamics
editThe pharmacodynamics of birch triterpenes are unknown.[1]
History
editThe US FDA approved birch triterpenes based on evidence from a clinical trial (NCT03068780[1][8]) of 223 participants with dystrophic and junctional epidermolysis bullosa.[6] The efficacy and safety of birch triterpenes for the treatment of partial-thickness wounds associated with inherited epidermolysis bullosa was evaluated in a randomized, double-blind, placebo-controlled trial in participants aged six months of age and older with dystrophic epidermolysis bullosa and junctional epidermolysis bullosa.[6] The primary endpoint was the proportion of subjects with first complete closure of the target wound by day 45 of the 90-day double-blind phase of the study, based on clinical assessment by the investigator.[6] The trial was conducted at 49 sites in 26 countries including Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, the Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, the United Kingdom, and the United States.[6] There were 14 participants enrolled in the United States and 209 participants were enrolled outside the United States.[6]
Society and culture
editLegal status
editIn 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.[9] The applicant for this medicinal product is Amryt Pharmaceuticals DAC.[9] Birch triterpenes was approved for medical use in the European Union in June 2022,[3][10] and in the United States in December 2023.[5][11][12]
References
edit- ^ a b c d e f "Filsuvez- birch triterpenes gel". DailyMed. 14 February 2024. Retrieved 3 March 2024.
- ^ "Filsuvez- birch triterpenes gel". DailyMed. 16 May 2024. Retrieved 14 July 2024.
- ^ a b c d e f g h i j k l m "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 (EMA). Archived (PDF) from the original on 15 July 2024. Retrieved 1 February 2024.
- ^ 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.
- ^ a b c d e f "Drug Trials Snapshots: Filsuvez". U.S. Food and Drug Administration (FDA). 18 December 2023. Archived from the original on 15 July 2024. Retrieved 14 July 2024.
This article incorporates text from this source, which is in the public domain.
- ^ 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.
- ^ "Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE)". ClinicalTrials.gov. Archived from the original on 30 March 2024. Retrieved 14 July 2024.
- ^ a b "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.
- ^ "Drug Approval Package: Filsuvez". U.S. Food and Drug Administration (FDA). 11 January 2024. Archived from the original on 25 February 2024. Retrieved 15 July 2024.
Further reading
edit- Rastogi S, Pandey MM, Kumar Singh Rawat A (January 2015). "Medicinal plants of the genus Betula--traditional uses and a phytochemical-pharmacological review". Journal of Ethnopharmacology. 159: 62–83. doi:10.1016/j.jep.2014.11.010. PMC 7126499. PMID 25449458.
