AstraZeneca announced that the FDA has approved Saphnelo (anifrolumab-fnia) for subcutaneous self-administration as a new autoinjector presentation for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The new option allows patients to receive Saphnelo outside of an infusion center setting, complementing the existing intravenous formulation.
According to AstraZeneca, Saphnelo will be available for once-weekly subcutaneous injection via a 120 mg autoinjector (the Saphnelo Pen) or a prefilled syringe. The company stated that the subcutaneous regimen uses the same active substance and is intended for the same SLE indication as the approved intravenous infusion, which is administered every four weeks by a healthcare professional.
The approval is based on data from the TULIP-SC Phase 3 trial, which evaluated subcutaneous anifrolumab in adults with moderate to severe SLE receiving standard therapy. In that study, subcutaneous Saphnelo met its primary endpoint by demonstrating a statistically significant reduction in disease activity compared with placebo and showed effects across several secondary and exploratory measures, including steroid tapering, time to first flare, and achievement of low disease activity or remission.
AstraZeneca noted that Saphnelo for subcutaneous administration is already approved in the European Union and Japan, and that the U.S. self-administration approval adds an additional dosing option for eligible SLE patients.
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