Avacopan

Avacopan, sold under the brand name Tavneos, is a medication used to treat anti-neutrophil cytoplasmic autoantibody-associated vasculitis.[2][3][5]

Avacopan
Clinical data
Trade namesTavneos
Other namesCCX168
AHFS/Drugs.comMonograph
License data
Routes of
administration		By mouth
Drug classComplement C5a receptor antagonist
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
ECHA InfoCard100.351.344
Chemical and physical data
FormulaC33H35F4N3O2
Molar mass581.656 g·mol−1
3D model (JSmol)
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
InChI
  • InChI=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
  • Key:PUKBOVABABRILL-YZNIXAGQSA-N

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).[3]

Avacopan was approved for medical use in Japan in September 2021,[4] and in the United States in October 2021.[2][5][6] It is the first orally-administered inhibitor of the complement C5a receptor approved by the U.S. Food and Drug Administration (FDA).[5] Avacopan is a complement 5a receptor antagonist[2] and a cytochrome P450 3A4 (CYP3A4) inhibitor.[2]

Medical uses

In the United States, avacopan is indicated as an adjunctive treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoids.[2][7]

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 (MPA).[3]

Society and culture

In November 2021, 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 Tavneos, intended, in combination with a rituximab or cyclophosphamide regimen, for the treatment of adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis.[8] The applicant for this medicinal product is Vifor Fresenius Medical Care Renal Pharma France.[8] The EMA considers avacopan to be a first-in-class medicine.[9] Avacopan was approved for medical use in the European Union in January 2022.[3]

Names

Avacopan is the international nonproprietary name (INN).[10]

References
  1. "Summary Basis of Decision - Tavneos". Health Canada. 28 July 2022. Archived from the original on 29 September 2022. Retrieved 29 September 2022.
  2. "Tavneos- avacopan capsule". DailyMed. Archived from the original on 1 November 2021. Retrieved 31 October 2021.
  3. "Tavneos EPAR". European Medicines Agency. 10 November 2021. Archived from the original on 17 March 2022. Retrieved 24 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. "ChemoCentryx Announces Approval in Japan of Tavneos (Avacopan) for the Treatment of ANCA-Associated Vasculitis". ChemoCentryx, Inc. (Press release). 27 September 2021. Archived from the original on 9 October 2021. Retrieved 11 October 2021.
  5. "ChemoCentryx Announces FDA Approval of Tavneos (avacopan) in ANCA-Associated Vasculitis". ChemoCentryx, Inc. (Press release). 8 October 2021. Archived from the original on 8 October 2021. Retrieved 11 October 2021.
  6. "Drug Approval Package: Tavneos". U.S. Food and Drug Administration (FDA). 4 November 2021. Archived from the original on 7 May 2022. Retrieved 7 May 2022.
  7. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000Approv.pdf Archived 7 May 2022 at the Wayback Machine
  8. "Tavneos: Pending EC decision". European Medicines Agency. 11 November 2021. Archived from the original on 12 November 2021. Retrieved 12 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. "First-in-class medicine recommended for treatment of rare blood vessel inflammation". European Medicines Agency (Press release). 12 November 2021. Archived from the original on 12 November 2021. Retrieved 12 November 2021.
  10. World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76". WHO Drug Information. 30 (3). hdl:10665/331020.

Further reading
  • "Avacopan". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02994927 for "A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis (ADVOCATE)" at ClinicalTrials.gov


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