AstraZeneca PLC
CRL Confirmed
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.
“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”

Provenance

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