AstraZeneca wins FDA approval for SAPHNELO autoinjector pen for lupus
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SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus
April 27, 2026 7:00 AM EDTFirst-in-class SAPHNELO Pen now offers greater flexibility and convenience, reaching a wider group of patients
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZenecas SAPHNELO® (anifrolumab-fnia) has been approved in the US for self-administration as a once-weekly autoinjector, the SAPHNELO Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of SAPHNELO led to a statistically significant and clinically... More
