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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: Lupus

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.

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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