FDA — authorised 24 March 2026
- Application: BLA761485
- Marketing authorisation holder: DENALI THERAPEUTICS INC.
- Local brand name: AVLAYAH
- Indication: INJECTION — POWDER,FOR SOLUTION
- Status: approved
🇺🇸 AVLAYAH in United States
FDA authorised AVLAYAH on 24 March 2026
Marketing authorisation
AVLAYAH in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is AVLAYAH approved in United States?
Yes. FDA authorised it on 24 March 2026.
Who is the marketing authorisation holder for AVLAYAH in United States?
DENALI THERAPEUTICS INC. holds the US marketing authorisation.