Tavneos

avacopan

Approval

ApplicationNDA 214487

Approval dateOct 7, 2021

Approval year2021

SponsorChemocentryx

FDA-approved use

To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids

Approval package

↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
↗ FDA Drug Trials Snapshot

Query with Claude

The fda-analyst skill answers natural-language questions about this approval by fetching the relevant FDA review PDFs at query time.

git clone https://github.com/cbetz/trove
cp -r trove/skills/fda-analyst ~/.claude/skills/

Example prompts for Tavneos:

"What was the basis for Tavneos's approval — what trials, what endpoints?"
"What adverse events did the FDA flag in the Tavneos medical review?"
"What regulatory pathway did Tavneos use — priority review, breakthrough, accelerated approval?"