Friday, June 19, 2026
Approved
approved Note: APPROVED — but note this sBLA is a CMC/manufacturing supplement, NOT a new indication. Brand name: ARCALYST (rilonacept), an IL-1 alpha/beta trap already approved for CAPS (2008), DIRA, and recurrent pericarditis (March 2021). No new indication or label expansion resulted from this action. Source: https://www.sec.gov/Archives/edgar/data/1730430/000110465926087545/knsa-20260630x10q.htm
Drug Information
- Drug Name
- ARCALYST →
- Application Type
- sBLA
- Approved As
- ARCALYST
Filing Details
- Company
- Kiniksa Pharmaceuticals International, plc
- Stock Ticker
- KNSA
- SEC CIK
- 0001730430
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue