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=== Medical uses ===
=== Medical uses ===
{{anchor|Medical uses}}
{{anchor|Medical uses}}
{{main|Birch triterpenes}}
{{Infobox drug
Filsuvez is a [[topical medication]] with birch bark extract as its [[active ingredient]].<ref name="Filsuvez EPAR">{{cite web | title=Filsuvez EPAR | website=[[European Medicines Agency]] (EMA) | date=13 April 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez | access-date=6 July 2022 | archive-date=6 July 2022 | archive-url=https://web.archive.org/web/20220706033550/https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> It is used to treat two types of [[epidermolysis bullosa]], dystrophic and junctional, targeting partial-thickness skin wounds. Common side effects include wound complications, skin reactions, infections, itching, and allergic reactions.<ref name="Filsuvez EPAR"/> Filsuvez was approved in the European Union in June 2022<ref name="Filsuvez EPAR">{{cite web | title=Filsuvez EPAR | website=[[European Medicines Agency]] (EMA) | date=13 April 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez | access-date=6 July 2022 | archive-date=6 July 2022 | archive-url=https://web.archive.org/web/20220706033550/https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web | title=Filsuvez Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1652.htm | access-date=3 March 2023 | archive-date=4 March 2023 | archive-url=https://web.archive.org/web/20230304070505/https://ec.europa.eu/health/documents/community-register/html/h1652.htm | url-status=live }}</ref> and in the United States in December 2023.<ref>{{cite press release | title=Chiesi Global Rare Diseases Receives FDA Approval for Filsuvez (birch triterpenes) topical gel for the Treatment of Epidermolysis Bullosa | website=Chiesi Global Rare Diseases | date=19 December 2023 | url=https://chiesirarediseases.com/media/fda-approval-for-filsuvez-topical-gel | access-date=22 December 2023 | archive-date=22 December 2023 | archive-url=https://web.archive.org/web/20231222000828/https://chiesirarediseases.com/media/fda-approval-for-filsuvez-topical-gel | url-status=live }}</ref><ref>{{cite web | title=Novel Drug Approvals for 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=19 December 2023 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 | access-date=22 December 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121035617/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 | url-status=live }}</ref> It is considered a [[first-in-class medication]] by the US Food and Drug Administration.<ref>{{cite report | title=New Drug Therapy Approvals 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=January 2024 | url=https://www.fda.gov/media/175253/download | format=PDF | access-date=9 January 2024 | archive-url=https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download | archive-date=10 January 2024 | url-status=live }}</ref>
| drug_name = Birch triterpenes
| image =
| width =
| alt =
| caption =

<!-- Clinical data -->
| pronounce =
| tradename = Filsuvez
| Drugs.com = {{drugs.com|parent|Filsuvez}}
| MedlinePlus =
| DailyMedID = Birch triterpenes
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_category =
| routes_of_administration = [[Topical administration|Topical]]
| class =
| ATCvet =
| ATC_prefix = None
| ATC_suffix =
| ATC_supplemental =

<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Filsuvez FDA label">{{Cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215064s000lbl.pdf |title=Archived copy |access-date=10 January 2024 |archive-date=3 January 2024 |archive-url=https://web.archive.org/web/20240103231631/https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215064s000lbl.pdf |url-status=live }}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Filsuvez EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = <!-- For countries not listed above -->

<!-- Pharmacokinetic data -->
| bioavailability =
| protein_bound =
| metabolism =
| metabolites =
| onset =
| elimination_half-life =
| duration_of_action =
| excretion =

<!-- Identifiers -->
| CAS_number =
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank =
| ChemSpiderID =
| UNII =
| KEGG = D12755
| ChEBI =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = Oleogel-S10

<!-- Chemical and physical data -->
| IUPAC_name =
| chemical_formula_ref =
| chemical_formula =
| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=
| K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge=
| molecular_weight =
| molecular_weight_comment =
| SMILES =
| StdInChI =
| StdInChI_comment =
| StdInChIKey =
| density =
| density_notes =
| melting_point =
| melting_high =
| melting_notes =
| boiling_point =
| boiling_notes =
| solubility =
| sol_units =
| specific_rotation =
}}

Birch bark, sold under the brand name '''Filsuvez''', is a [[medication]] that is used to treat [[epidermolysis bullosa]].<ref name="Filsuvez EPAR" />

The most common side effects with Filsuvez include wound complications.<ref name="Filsuvez EPAR" /> Other common side effects include skin reactions at the application site, wound infections, pruritus (itching), and hypersensitivity (allergic) reactions.<ref name="Filsuvez EPAR" />

Epidermolysis bullosa is an inherited disease of the skin that makes the skin very fragile and causes severe blistering and scarring.<ref name="Filsuvez EPAR" /> Filsuvez is used in two types of epidermolysis bullosa, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, to treat partial-thickness skin wounds.<ref name="Filsuvez EPAR" /> These are wounds where the upper layers of the skin have been damaged.<ref name="Filsuvez EPAR" />

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.<ref name="Filsuvez EPAR" /> The US [[Food and Drug Administration]] (FDA) considers it to be a [[first-in-class medication]].<ref>{{cite report | title=New Drug Therapy Approvals 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=January 2024 | url=https://www.fda.gov/media/175253/download | format=PDF | access-date=9 January 2024 | archive-url=https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download | archive-date=10 January 2024 | url-status=live }}</ref>

==== Legal status ====
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]].<ref name="Filsuvez: Pending EC decision" /> The applicant for this medicinal product is Amryt Pharmaceuticals DAC.<ref name="Filsuvez: Pending EC decision" /> Filsuvez will be available as a gel for cutaneous use.<ref name="Filsuvez: Pending EC decision" /> 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]].<ref name="Filsuvez: Pending EC decision" /> It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound healing and closure.<ref name="Filsuvez: Pending EC decision">{{cite web | title=Filsuvez: Pending EC decision | website=[[European Medicines Agency]] (EMA) | date=22 April 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/filsuvez | access-date=22 April 2022 | archive-date=22 April 2022 | archive-url=https://web.archive.org/web/20220422155628/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/filsuvez | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Filsuvez was approved for medical use in the European Union in June 2022,<ref name="Filsuvez EPAR">{{cite web | title=Filsuvez EPAR | website=[[European Medicines Agency]] (EMA) | date=13 April 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez | access-date=6 July 2022 | archive-date=6 July 2022 | archive-url=https://web.archive.org/web/20220706033550/https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web | title=Filsuvez Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1652.htm | access-date=3 March 2023 | archive-date=4 March 2023 | archive-url=https://web.archive.org/web/20230304070505/https://ec.europa.eu/health/documents/community-register/html/h1652.htm | url-status=live }}</ref> and in the United States in December 2023.<ref>{{cite press release | title=Chiesi Global Rare Diseases Receives FDA Approval for Filsuvez (birch triterpenes) topical gel for the Treatment of Epidermolysis Bullosa | website=Chiesi Global Rare Diseases | date=19 December 2023 | url=https://chiesirarediseases.com/media/fda-approval-for-filsuvez-topical-gel | access-date=22 December 2023 | archive-date=22 December 2023 | archive-url=https://web.archive.org/web/20231222000828/https://chiesirarediseases.com/media/fda-approval-for-filsuvez-topical-gel | url-status=live }}</ref><ref>{{cite web | title=Novel Drug Approvals for 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=19 December 2023 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 | access-date=22 December 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121035617/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 | url-status=live }}</ref>


== See also ==
== See also ==

Latest revision as of 19:47, 1 February 2024

A Russian birch bark letter from the 14th century
Birchbark shoes

Birch bark or birchbark is the bark of several Eurasian and North American birch trees of the genus Betula.

The strong and water-resistant cardboard-like bark can be easily cut, bent, and sewn, which has made it a valuable building, crafting, and writing material, since pre-historic times. Today, birch bark remains a popular type of wood for various handicrafts and arts.

Birch bark also contains substances of medicinal and chemical interest. Some of those products (such as betulin) also have fungicidal properties that help preserve bark artifacts, as well as food preserved in bark containers.

Collection and storage[edit]

Birchbark box with lid and bottom of birch wood

Removing birch bark from live trees is harmful to tree health and should be avoided. Instead, it can be removed fairly easily from the trunk or branches of dead wood, by cutting a slit lengthwise through the bark and pulling or prying it away from the wood. The best time for collection is spring or early summer, as the bark is of better quality and most easily removed.

Removing the outer (light) layer of bark from the trunk of a living tree may not kill it, but probably weakens it and makes it more prone to infections. Removal of the inner (dark) layer, the phloem, kills the tree by preventing the flow of sap to the roots.

To prevent it from rolling up during storage, the bark should be spread open and kept pressed flat.

Working[edit]

Birch bark can be cut with a sharp knife, and worked like cardboard. For sharp bending, the fold should be scored (scratched) first with a blunt stylus.

Fresh bark can be worked as is; bark that has dried up (before or after collection) should be softened by steaming, by soaking in warm water, or over a fire.

Uses[edit]

A birch bark longhouse on Whitefish Island in Canada
Finnish fishing net weights made out of birch bark and stones
North American birchbark canoe
Birchbark knife handle

Birch bark was a valuable construction material in any part of the world where birch trees were available. Containers such as wrappings, bags, baskets, boxes, or quivers were made by most societies well before pottery was invented[citation needed]. Other uses include:

Birch bark also makes an outstanding tinder, as the inner layers will stay dry even through heavy rainstorms.

Medical uses[edit]

Filsuvez is a topical medication with birch bark extract as its active ingredient.[8] It is used to treat two types of epidermolysis bullosa, dystrophic and junctional, targeting partial-thickness skin wounds. Common side effects include wound complications, skin reactions, infections, itching, and allergic reactions.[8] Filsuvez was approved in the European Union in June 2022[8][9] and in the United States in December 2023.[10][11] It is considered a first-in-class medication by the US Food and Drug Administration.[12]

See also[edit]

  • Mazinibaganjigan – Indigenous Great Lakes art form
  • Wiigwaasabak – Birch bark scrolls for ceremonial use by the Ojibwa (Anishinaabe) people of North America
  • Wiigwaasi-makak – Box made from birch bark
  • Magewappa – Japanese wood craft
  • Lapti – Traditional bast fiber footwear of Europe

References[edit]

  1. ^ Vennum T, Weber C, Nyholm E (1999). Earl's Canoe: A Traditional Ojibwe Craft. Smithsonian Center for Folklife Programs and Cultural Studies. Archived from the original on 4 January 2013. Retrieved 3 December 2012.
  2. ^ Hayes D (2002). Historical Atlas of Canada: Canada's History Illustrated with Original Maps. Vancouver: Douglas & McIntyre Ltd. p. 152.
  3. ^ Boszhardt RF (2003). Deep Cave Rock Art in the Upper Mississippi Valley. St. Paul: Prairie Smoke Press. pp. 54–55. ISBN 0-9704482-3-6.
  4. ^ Losty JP (1982). The art of the book in India. British Library. Reference Division. London: British Library. ISBN 0904654788. OCLC 8653520.
  5. ^ Salomon R, Barnard M, Allchin FR (1999). Ancient Buddhist scrolls from Gandhāra: the British Library Kharoṣṭhī fragments. London: The British Library. ISBN 0712346112. OCLC 263439456.
  6. ^ Kozowyk PR, Soressi M, Pomstra D, Langejans GH (August 2017). "Experimental methods for the Palaeolithic dry distillation of birch bark: implications for the origin and development of Neandertal adhesive technology". Scientific Reports. 7 (1): 8033. Bibcode:2017NatSR...7.8033K. doi:10.1038/s41598-017-08106-7. PMC 5579016. PMID 28860591.
  7. ^ Schmidt P, Blessing M, Rageot M, Iovita R, Pfleging J, Nickel KG, et al. (September 2019). "Birch tar production does not prove Neanderthal behavioral complexity". Proceedings of the National Academy of Sciences of the United States of America. 116 (36): 17707–17711. Bibcode:2019PNAS..11617707S. doi:10.1073/pnas.1911137116. PMC 6731756. PMID 31427508.
  8. ^ a b c "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.
  9. ^ "Filsuvez Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  10. ^ "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.
  11. ^ "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.
  12. ^ 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.

Further reading[edit]

Winter bark etching on canoe
  • McPhee J (1975). The Survival of the Bark Canoe. New York: Farrar, Straus and Giroux.
  • Adney ET, Chapelle H (2014). Bark Canoes and Skin Boats of North America. Skyhorse Publishing, Inc.
  • Jennings J (2004). Bark Canoes: The Art and Obsession of Tappan Adney. Firefly Books Ltd.
  • Behne CT, ed. (2010). The Travel Journals of Tappan Adney, 1887-1890. Estate of Tappan Adney.
  • Goode FW (2012). Ojibwe Birch Bark Canoes: Anishinaabe Wigwassi-Jiimaan. Beaver Bark Canoes.

External links[edit]