SAPHNELO (AstraZeneca Pty Ltd)
Product name
SAPHNELO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
235 (255 working days)
Active ingredients
anifrolumab
Registration type
NCE/NBE
Indication
SAPHNELO (anifrolumab) (concentrated injection) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (SLE), despite standard therapy.
The safety and efficacy of SAPHNELO have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.