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# FDA Approves AstraZeneca Lupus Therapy
- URL: https://www.fdaweb.com/fda-approves-astrazeneca-lupus-therapy/
- Published: 2021-08-02T12:00:00.000Z
- Updated: 2026-09-14T17:08:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149838

FDA has approved an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Approval was based on data from the two TULIP Phase 3 trials and the MUSE Phase 2I trial. Data showed that “more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy,” the company says.

Adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough, AstraZeneca says.