FDA — authorised 27 February 2008
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Status: approved
🇺🇸 Arcalyst in United States
FDA authorised Arcalyst on 27 February 2008
Marketing authorisations
FDA — authorised 27 February 2008
- Application: BLA125249
- Marketing authorisation holder: KINIKSA PHARMACEUTICALS (UK), LTD.
- Local brand name: ARCALYST
- Indication: VIAL — SINGLE-USE
- Status: approved
Arcalyst in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Arcalyst approved in United States?
Yes. FDA authorised it on 27 February 2008; FDA authorised it on 27 February 2008.
Who is the marketing authorisation holder for Arcalyst in United States?
REGENERON PHARMACEUTICALS holds the US marketing authorisation.