Avacopan Explained

Width:250
Tradename:Tavneos
Dailymedid:Avacopan
Pregnancy Au:D
Pregnancy Au Comment:[1]
Routes Of Administration:By mouth
Class:Complement C5a receptor antagonist
Atc Prefix:L04
Atc Suffix:AJ05
Legal Au:S4
Legal Au Comment:[2]
Legal Ca:Rx-only
Legal Ca Comment:[3]
Legal Uk:POM
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:1346623-17-3
Pubchem:49841217
Drugbank:DB15011
Chemspiderid:52083514
Unii:O880NM097T
Kegg:D11093
Chembl:3989871
Pdb Ligand:EFD
Synonyms:CCX168
C:33
H:35
F:4
N:3
O:2
Smiles:CC1=CC=C(NC(=O)[C@H]2CCCN([C@H]2C2=CC=C(NC3CCCC3)C=C2)C(=O)C2=C(F)C=CC=C2C)C=C1C(F)(F)F
Stdinchi:1S/C33H35F4N3O2/c1-20-12-15-25(19-27(20)33(35,36)37)39-31(41)26-10-6-18-40(32(42)29-21(2)7-5-11-28(29)34)30(26)22-13-16-24(17-14-22)38-23-8-3-4-9-23/h5,7,11-17,19,23,26,30,38H,3-4,6,8-10,18H2,1-2H3,(H,39,41)/t26-,30-/m0/s1
Stdinchikey:PUKBOVABABRILL-YZNIXAGQSA-N

Avacopan, sold under the brand name Tavneos, is a medication used to treat anti-neutrophil cytoplasmic autoantibody-associated vasculitis.[6] 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,[7] and in the United States in October 2021.[8] 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.[9]

Medical uses

In the United States, avacopan is indicated as an adjunctive treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoids.[10]

In the European Union, avacopan, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis.

History

The FDA approved avacopan based on evidence from a clinical trial of 330 participants with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. In the clinical trial, participants were randomly assigned to receive avacopan or placebo for 52 weeks. Participants in the placebo group received a glucocorticoid taper over 20 weeks. Neither the participants nor healthcare providers knew which medication was being given. Participants in both groups received background immunosuppressive treatment (cyclophosphamide or rituximab) and were allowed to receive additional glucocorticoids. The benefit of avacopan in comparison to placebo was assessed by proportion of participants who achieved remission at week 26 and sustained remission at week 52. Data from this trial were also analyzed for the assessment of side effects. The trial was conducted at 143 sites in 18 countries including the United States. This trial assessed both efficacy and safety. In the clinical trial, a greater proportion of participants who received avacopan for one year with other medicines (including glucocorticoids) achieved sustained disease remission compared to participants who received other medicines without avacopan. The proportion of participants who achieved remission after six months of treatment was similar.[11]

Society and culture

Legal status

In November 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tavneos, intended, in combination with a rituximab or cyclophosphamide regimen, for the treatment of adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis. The applicant for this medicinal product is Vifor Fresenius Medical Care Renal Pharma France.[12] The EMA considers avacopan to be a first-in-class medicine.[13] Avacopan was approved for medical use in the European Union in January 2022.[14] [15]

The FDA granted the application for avacopan orphan drug designation.[9]

Names

Avacopan is the international nonproprietary name.[16]

Further reading

Notes and References

  1. Web site: Archived copy . 2 January 2024 . 2 January 2024 . https://web.archive.org/web/20240102022434/https://www.tga.gov.au/resources/auspmd/tavneos . live .
  2. Web site: Tavneos (Vifor Pharma Pty Ltd) . Therapeutic Goods Administration (TGA) . 16 February 2023 . 29 April 2023 . 27 March 2023 . https://web.archive.org/web/20230327062343/https://www.tga.gov.au/resources/prescription-medicines-registrations/tavneos-vifor-pharma-pty-ltd . live .
  3. Web site: Summary Basis of Decision - Tavneos . Health Canada . 28 July 2022 . 29 September 2022 . 29 September 2022 . https://web.archive.org/web/20220929050351/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00597&lang=en . live .
  4. Web site: Tavneos (Avacopan) Summary of Product Characteristics (SmPC) . emc . 26 May 2022 . 23 July 2023 . 24 July 2023 . https://web.archive.org/web/20230724001757/https://www.medicines.org.uk/emc/product/13744/smpc . live .
  5. Web site: Tavneos- avacopan capsule . DailyMed . 31 October 2021 . 1 November 2021 . https://web.archive.org/web/20211101041949/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c93cbc0b-29a3-46a5-9c85-41815ea5cf4a . live .
  6. ChemoCentryx Announces FDA Approval of Tavneos (avacopan) in ANCA-Associated Vasculitis . ChemoCentryx, Inc. . 8 October 2021 . 11 October 2021 . 8 October 2021 . https://web.archive.org/web/20211008203634/https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-announces-fda-approval-tavneostm-avacopan-anca . live .
  7. ChemoCentryx Announces Approval in Japan of Tavneos (Avacopan) for the Treatment of ANCA-Associated Vasculitis . ChemoCentryx, Inc. . 27 September 2021 . 11 October 2021 . 9 October 2021 . https://web.archive.org/web/20211009005211/https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-announces-approval-japan-tavneostm-avacopan . live .
  8. Web site: Drug Approval Package: Tavneos . U.S. Food and Drug Administration (FDA) . 4 November 2021 . 7 May 2022 . 7 May 2022 . https://web.archive.org/web/20220507191220/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000TOC.cfm . live .
  9. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 . U.S. Food and Drug Administration (FDA) . 13 May 2022 . PDF . 22 January 2023 . 6 December 2022 . https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download . live .
  10. Web site: 7 October 2021 . Center for Drug Evaluation and Research - Approval Package for: Application Number: 214487Orig1s000 . live . https://web.archive.org/web/20220507191219/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000Approv.pdf . 7 May 2022 . U.S. Food and Drug Administration (FDA) .
  11. Web site: Drug Trials Snapshot: Tavneos . U.S. Food and Drug Administration (FDA) . 7 October 2021 . 23 July 2023 . 23 July 2023 . https://web.archive.org/web/20230723204524/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-tavneos . live .
  12. Web site: Tavneos: Pending EC decision . European Medicines Agency . 11 November 2021 . 12 November 2021 . 12 November 2021 . https://web.archive.org/web/20211112122704/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tavneos . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. First-in-class medicine recommended for treatment of rare blood vessel inflammation . European Medicines Agency . 12 November 2021 . 12 November 2021 . 12 November 2021 . https://web.archive.org/web/20211112122545/https://www.ema.europa.eu/en/news/first-class-medicine-recommended-treatment-rare-blood-vessel-inflammation . live .
  14. Web site: Tavneos EPAR . European Medicines Agency . 10 November 2021 . 24 April 2022 . 17 March 2022 . https://web.archive.org/web/20220317090750/https://www.ema.europa.eu/en/medicines/human/EPAR/tavneos . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. Web site: Tavneos Product information . Union Register of medicinal products . 3 March 2023 . 4 March 2023 . https://web.archive.org/web/20230304093743/https://ec.europa.eu/health/documents/community-register/html/h1605.htm . live .
  16. ((World Health Organization)) . 2016 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76 . WHO Drug Information . 30 . 3 . 10665/331020 . free . World Health Organization .

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