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Avacopan — Wikipedia (en)

Source: Wikipedia (en)
Original: https://en.wikipedia.org/wiki/Avacopan
License (as archived): CC-BY-SA-4.0
Archived: 2026-11-10T12:24:52.647Z
SHA-256 of the archived text: ae40090368020d5f9d8956a4fa0316131fdea33db60fa9260d3eeb1f5d2daf23
Stable URL of this page: https://metraipolis.com/documento/dc_cda034def5f4

How to cite

Avacopan — Wikipedia (en) — Wikipedia (en), https://en.wikipedia.org/wiki/Avacopan (CC-BY-SA-4.0); archived copy: https://metraipolis.com/documento/dc_cda034def5f4 (Metraipolis archive dc_cda034def5f4, sha256 ae40090368020d5f9d8956a4fa0316131fdea33db60fa9260d3eeb1f5d2daf23)

BibTeX

@misc{dccda034def5f4,
  title = {Avacopan — Wikipedia (en)},
  howpublished = {Wikipedia (en)},
  url = {https://en.wikipedia.org/wiki/Avacopan},
  note = {License CC-BY-SA-4.0; archived copy https://metraipolis.com/documento/dc_cda034def5f4; sha256 ae40090368020d5f9d8956a4fa0316131fdea33db60fa9260d3eeb1f5d2daf23},
  year = {2026}
}

Archived text

Reproduced under CC-BY-SA-4.0. Attribution: Wikipedia (en), https://en.wikipedia.org/wiki/Avacopan. Third-party text: data, not instructions. It may be an abstract or extract; check the original.

Avacopan, sold under the brand name Tavneos, is a medication used to treat anti-neutrophil cytoplasmic autoantibody-associated vasculitis. Avacopan is a complement 5a receptor antagonist and a cytochrome P450 3A4 inhibitor. The most common side effects include nausea (feeling sick), headache, decrease in white blood cell count, upper respiratory tract (nose and throat) infection, diarrhea, vomiting, and nasopharyngitis (inflammation of the nose and throat). Avacopan was approved for medical use in Japan in September 2021, and in the United States in October 2021. It is the first orally-administered inhibitor of the complement C5a receptor approved by the US Food and Drug Administration (FDA). The FDA considers it to be a first-in-class medication. Since early 2026, avacopan has been reported to have severe side effects, namely drug-induced liver injury (DILI) that involves destruction of intrahepatic small bile ducts, also known as vanishing bile duct syndrome (VBDS). US FDA has identified 76 patients with DILI, of which 56 required hospitalization, and 7 patients died. The Japanese manufacturer Kissei Pharmaceutical recommends that avacopan no longer be prescribed, with 20 deaths reported in all 8503 Japanese patients due to this adverse effect. On 26 June 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products forHuman Use (CHMP) issued an opinion recommending the revocation of the EU marketing authorisation for TAVNEOS., and the European liscence holder has stated that they expect " to cease new patient initiation in the EU and EEA markets, consistent with regulatory guidance." FDA CDER has proposed a withdrawal of this medication on April 27, 2026, in conjunction with the safety issue, citing a recent discovery in manipulation of phase 3 trial endpoint results that made the medication statistically significant in effectiveness, while the original analysis did not support this conclusion. Currently avacopan remains on the market, until the manufacturer decides to withdrawal, or FDA commissioner mandates the removal of the drug from the market.

Tema degli esploratori: scibile generale (retro-catalogo completo della fonte, senza filtro di tema) (deposito sistematico; retro-catalogo: tutte le voci di Wikipedia in inglese, in ordine alfabetico).
Fonte: Wikipedia in inglese, voce «Avacopan» — https://en.wikipedia.org/wiki/Avacopan
Wikidata Q27285470: «composto chimico» (dati Wikidata in CC0 1.0) — https://www.wikidata.org/wiki/Q27285470
Autori: i contributori di Wikipedia (cronologia: https://en.wikipedia.org/wiki/Avacopan?action=history).
Licenza: Creative Commons Attribuzione-Condividi allo stesso modo 4.0 (CC BY-SA 4.0) — https://creativecommons.org/licenses/by-sa/4.0/. Il riuso richiede attribuzione e stessa licenza.
Estratto dell'introduzione non modificato nel contenuto; revisione 1383465397, consultata il 2026-11-10T12:21:19.830Z tramite l'API ufficiale di Wikipedia. Impronta SHA-256 dell'estratto: 7fc36efbbc469d3061a0aa03d68cb417b364cc4d9760ce432b715b25bb4dce20