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| Clinical data | |
|---|---|
| Trade names | Tavneos |
| Other names | CCX168 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a622023 |
| License data | |
| Pregnancy category | |
| Routes of administration | By mouth |
| Drug class | Complement C5a receptor antagonist |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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| CAS Number | |
| PubChemCID | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| PDB ligand | |
| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.351.344 |
| Chemical and physical data | |
| Formula | C33H35F4N3O2 |
| Molar mass | 581.656 g·mol−1 |
| 3D model (JSmol) | |
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Avacopan, sold under the brand nameTavneos, is amedication used to treatanti-neutrophil cytoplasmic autoantibody-associated vasculitis.[5][6][8] Avacopan is a complement 5a receptor antagonist[5] and acytochrome P450 3A4 inhibitor.[5]
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, andnasopharyngitis (inflammation of the nose and throat).[6]
Avacopan was approved for medical use in Japan in September 2021,[7] and in the United States in October 2021.[5][8][9] It is the first orally-administered inhibitor of thecomplement C5a receptor approved by the USFood and Drug Administration (FDA).[8] The FDA considers it to be afirst-in-class medication.[10]
In the United States, avacopan isindicated as anadjunctive treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis andmicroscopic polyangiitis) in combination with standard therapy includingglucocorticoids.[5][11]
In the European Union, avacopan, in combination with arituximab orcyclophosphamide regimen, is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis.[6]
Avacopan (ChemoCentryx code name: CCX168) was discovered and developed by ChemoCentryx Inc., a California-based biotech company, which was acquired by Amgen in 2022, one year after the FDA approval of TAVNEOS (avacopan).
The FDA approved avacopan based on evidence from a clinical trial of 330 participants with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.[12] In the clinical trial, participants were randomly assigned to receive avacopan or placebo for 52 weeks.[12] Participants in the placebo group received a glucocorticoid taper over 20 weeks.[12] Neither the participants nor healthcare providers knew which medication was being given.[12] Participants in both groups received background immunosuppressive treatment (cyclophosphamide or rituximab) and were allowed to receive additional glucocorticoids.[12] 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.[12] Data from this trial were also analyzed for the assessment of side effects.[12] The trial was conducted at 143 sites in 18 countries including the United States.[12] This trial assessed both efficacy and safety.[12] 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.[12] The proportion of participants who achieved remission after six months of treatment was similar.[12]
In November 2021, theCommittee for Medicinal Products for Human Use of theEuropean 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.[13] The applicant for this medicinal product is Vifor Fresenius Medical Care Renal Pharma France.[13] The EMA considers avacopan to be afirst-in-class medicine.[14] Avacopan was approved for medical use in the European Union in January 2022.[6][15]
The FDA granted the application for avacopanorphan drug designation.[10]
Avacopan is theinternational nonproprietary name.[16]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.