Drug profile · INN
avacopan
TAVNEOS
avacopan (TAVNEOS) is a c5a anaphylatoxin chemotactic receptor antagonist. Associated with Seqirus (Australia) Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
Drug details — avacopan
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L04)
- Route
- ORAL
- Patents
- 1
- Programs
- 1
- Data quality
- 0.84
Quick answer
avacopan (TAVNEOS) is a c5a anaphylatoxin chemotactic receptor antagonist. Associated with Seqirus (Australia) Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
C5a anaphylatoxin chemotactic receptor antagonist
Primary target: C5a anaphylatoxin chemotactic receptor 1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
Recent coverage
EMA Tightens Liver Safety Checks for Tavneos After Fatal Cases
EMA's PRAC has tightened monitoring and stopping rules for Tavneos (avacopan) after reviewing serious liver injury cases, including fatal outcomes. The update adds liver injury as a rare side effect and creates a new regulatory watchpoint for Amgen and ANCA-associated vasculitis teams.
Kissei Pharmaceutical Halts Tavneos Use Amid Deaths
Structured plan for Kissei Pharmaceutical Halts Tavneos Use Amid Deaths
Amgen's Commitment to Tavneos Amid Concerns in Japan
Amgen reaffirms its support for Tavneos despite a liver toxicity report from Japan. This article explores the implications for the pharmaceutical industry.
Pipeline programs
Related & competitor drugs
Related patents
Frequently asked questions
What is avacopan?
avacopan (TAVNEOS) is a c5a anaphylatoxin chemotactic receptor antagonist. Associated with Seqirus (Australia) Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for avacopan?
TAVNEOS is a marketed brand name for avacopan. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of avacopan?
avacopan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.