FDA
At-home Saphnelo pen wins FDA approval for lupus
FDA has approved Saphnelo (anifrolumab) for subcutaneous self‑administration using a once‑weekly autoinjector pen in adults with moderate to severe systemic lupus erythematosus (SLE), in addition to standard therapy. Building on Saphnelo's previous approval as a clinic‑based intravenous infusion, the newly approved autoinjector expands access by allowing patients to self‑administer treatment at home or with caregiver support.
Approval was supported by the phase 3 TULIP‑SC trial, a randomized, double‑blind study of 367 adults with moderate to severe SLE receiving background standard of care. At 52 weeks, patients receiving subcutaneous anifrolumab showed a statistically significant improvement in overall lupus disease activity compared with placebo, based on a composite clinical assessment (BICLA) that evaluates improvement across all affected organ systems. In predefined analyses, nearly one‑third of treated patients achieved clinical remission, and approximately 40% reached a state of low disease activity. Patients receiving anifrolumab also showed meaningful steroid‑sparing effects, tapering to ≤7.5 mg/day of oral corticosteroids.
The safety profile of SC, self-administered Saphnelo was consistent with the established safety profile of the IV-administered formulation. No new safety signals were identified.
“The FDA approval of self-administered Saphnelo marks an exciting milestone for people living with lupus,” said Louise Vetter, President and CEO, the Lupus Foundation of America. “Being able to self-inject at home offers greater convenience for those managing SLE, helping to reduce the burden of frequent clinic visits and maintain access to an effective treatment option.”
Source: AstraZeneca. (2026, April 27). Press release. Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus