Saphnelo (anifrolumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- anifrolumab
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Lupus Erythematosus, Systemic
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Mon 14 Feb 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004975
- ATC
- L04AG11
- Official record
- www.ema.europa.eu
Indication
Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.
Regulatory milestones
Fri 24 Apr 2026🇺🇸 FDA approval
FDA approves Saphnelo (anifrolumab-fnia), a new medicine
Astrazeneca Ab; BLA761451; New biologic; injection, vial · source
Same substance in other markets
- 🇺🇸 Saphnelo Approved · Astrazeneca Ab
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.