AstraZeneca PLC
Saphnelo
systemic lupus erythematosus
Resolved
154days ago
FDA decision · Feb 3, 2026
What's at stake
An FDA complete response letter on Saphnelo for systemic lupus erythematosus is in focus around Feb 3, 2026.
Primary source
· SEC 6-K
verified 14h ago
“The US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) for subcutaneous administration in adult patients with systemic lupus erythematos”