Pegadricase + Sirolimus PDUFA Date (Swedish Orphan Biovitrum (Sobi))

Name: FDA PDUFA Decision: Pegadricase + Sirolimus
Start: 2026-06-27

FDA PDUFA decision date for Pegadricase + Sirolimus is June 27, 2026. Developed by Swedish Orphan Biovitrum (Sobi). Indication: Uncontrolled gout (refractory). Current status: CRL.

Indication

Uncontrolled gout (refractory)

Regulatory details

Company: Swedish Orphan Biovitrum (Sobi)
Therapeutic area: Immunology / Rheumatology
Application type: BLA
Review type: Standard
PDUFA date: 2026-06-27
Outcome: CRL

Pegadricase + Sirolimus PDUFA Date — Swedish Orphan Biovitrum (Sobi)