Avacopan

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Avacopan
Avacopan.svg
Names
Trade namesTavneos, Vynpenta
Other namesCCX168
Clinical data
Drug classComplement C5a receptor antagonist
Main usesGranulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA)[1]
Side effectsNausea, headache, low white blood cells, upper respiratory tract infection, diarrhea, vomiting, inflammation of the nose and throat[1]
Routes of
use
By mouth
Typical dose30 mg BID[2]
External links
AHFS/Drugs.comMonograph
US NLMAvacopan
Legal
License data
Legal status
Chemical and physical data
FormulaC33H35F4N3O2
Molar mass581.656 g·mol−1
3D model (JSmol)
  • 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=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

Avacopan, sold under the brand name Tavneos, is a medication used to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.[2] This includes granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).[1] It is taken by mouth.[2]

Common side effects include nausea, headache, low white blood cells, upper respiratory tract infection, diarrhea, vomiting, and inflammation of the nose and throat.[1] Other side effects may include liver problems, allergic reactions, and infections.[2] Safety is unclear in pregnancy.[2] It is a complement 5a receptor (C5aR) antagonist.[2]

Avacopan was approved for medical use in Japan and United States in 2021, and Europe in 2022.[4][2][1] In the United Kingdom a month of medication costs the NHS about £5500 as of 2022.[5] This amount in the United States costs about 14,400 USD.[6]

Medical uses

In the United States, it is used 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).[1]

Dosage

It is generally used at a dose of 30 mg twice per day.[2]

History

It is the first orally-administered inhibitor of the complement C5a receptor approved in the USA.[8]

Society and culture

Legal status

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.[9] The applicant for this medicinal product is Vifor Fresenius Medical Care Renal Pharma France.[9] The EMA considers avacopan to be a first-in-class medicine.[10] Avacopan was approved for medical use in the European Union in January 2022.[1]

Names

Avacopan is the international nonproprietary name (INN).[11]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "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.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 "Tavneos- avacopan capsule". DailyMed. Archived from the original on 1 November 2021. Retrieved 31 October 2021.
  3. "Summary Basis of Decision - Tavneos". Health Canada. 28 July 2022. Archived from the original on 29 September 2022. Retrieved 29 September 2022.
  4. 4.0 4.1 "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. "Avacopan". SPS - Specialist Pharmacy Service. 23 October 2017. Archived from the original on 6 December 2021. Retrieved 25 October 2022.
  6. "Avacopan". Goodrx. Archived from the original on 25 October 2022. Retrieved 25 October 2022.
  7. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000Approv.pdf Archived 7 May 2022 at the Wayback Machine[bare URL PDF]
  8. "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.
  9. 9.0 9.1 "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.
  10. "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.
  11. 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

External links

External sites:
Identifiers:
  • Clinical trial number NCT02994927 for "A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis (ADVOCATE)" at ClinicalTrials.gov