SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus
AstraZeneca PLC Ordinary Shares (AZN)
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Source: Business Wire
First-in-class SAPHNELO Pen now offers greater flexibility and convenience, reaching a wider group of patients WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s 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 meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy.1,2 Full results from the TULIP-SC trial were published in Arthritis & Rheumatology in January 2026.The safety profile observed was consistent with the known clinical profile of SAPHNELO administered as an intravenous (IV) infusion.3-5Sus
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