AstraZeneca has announced that its Saphnelo (anifrolumab) has been approved by the US Food and Drug Administration (FDA) for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE).
The US approval was based on the Phase III TULIP-SC trial, which showed that subcutaneous administration of Saphnelo significantly reduced disease activity compared with placebo in participants with moderate-to-severe SLE on standard therapy.
The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.
AstraZeneca acquired global rights to Saphnelo through a licensing agreement with Medarex in 2004.
This co-promotion option ended when Bristol-Myers Squibb (BMS) acquired Medarex in 2009. Under an agreement updated in 2025, AstraZeneca will pay BMS a mid-teens royalty on US sales.
Dr Susan Manzi, Chair of the Allegheny Health Network (AHN) Medicine Institute, Director of the Lupus Center of Excellence at the AHN Autoimmunity Institute and principal investigator of the TULIP-SC trial, said: "The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients."
With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, added: "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.
Why this matters
SLE is a significant cause of death among young women in the US, particularly affecting Asian, Black and Hispanic populations.
While oral corticosteroids are frequently used for symptom relief, they have adverse effects and do not address the disease's root causes.
Recent clinical guidelines stress the importance of achieving remission or low disease activity while minimising corticosteroid use.
To date, more than 40,000 patients have received Saphnelo globally. It is the first biologic treatment to show remission data from a four-year placebo-controlled Phase III trial (TULIP-LTE) using the DORIS remission criteria.