AstraZeneca’s Saphnelo Gains FDA Approval for Self-Administration, Expanding Lupus Treatment Access

AstraZeneca (LON: AZN) announced FDA approval for a subcutaneous self-administration option of Saphnelo (anifrolumab) via a new autoinjector pen.

This approval marks a significant step in expanding the accessibility and convenience of this treatment for adult patients battling systemic lupus erythematosus (SLE).

The FDA’s decision was influenced by positive outcomes from the Phase III TULIP-SC trial. The trial demonstrated that subcutaneous administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in patients with moderate to severe SLE already receiving standard therapy.

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The Saphnelo Pen offers a once-weekly self-injection, providing patients greater flexibility in managing their condition.

The approval broadens the reach of Saphnelo, potentially benefiting a wider group of patients who prefer or require self-administration options. The safety profile observed in the TULIP-SC trial aligned with the established clinical profile of Saphnelo when administered as an intravenous infusion.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, commented: “Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. 

“The approval of the Saphnelo Pen represents a significant step forward in expanding Saphnelo’s clinical benefits to more people living with systemic lupus erythematosus.”