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Saphnelo FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2021.

FDA Approved: Yes (First approved July 30, 2021)
Brand name: Saphnelo
Generic name: anifrolumab-fnia
Dosage form: Injection
Company: AstraZeneca
Treatment for: Systemic Lupus Erythematosus

Saphnelo (anifrolumab) is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.

  • Limitations of Use: The efficacy of Saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of Saphnelo is not recommended in these situations.
  • Saphnelo is a first-in-class type I interferon receptor antibody. 
  • Most SLE patients have increased type I IFN signalling, which is associated with increased disease activity and severity. Saphnelo works by binding to subunit 1 of the type I IFN receptor, blocking the activity of type I IFNs.
  • Saphnelo is administered via intravenous infusion over a 30-minute period every 4 weeks.
  • Saphnelo can cause serious adverse reactions including serious Infections and hypersensitivity reactions. Common adverse drug reactions include nasopharyngitis, upper respiratory tract infections, bronchitis, infusion related reactions, herpes zoster and cough.

Development timeline for Saphnelo

Aug  2, 2021Approval FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus
Jun  2, 2021Anifrolumab Showed Benefit Across Different Measures of Skin and Joint Disease Activity in Patients with Systemic Lupus Erythematosus
Nov 11, 2019Anifrolumab Demonstrated Superiority Across Multiple Efficacy Endpoints in Patients with Systemic Lupus Erythematosus in Phase III TULIP 2 Trial
Aug 29, 2019Anifrolumab Phase III Trial Meets Primary Endpoint in Systemic Lupus Erythematosus

Further information

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