AstraZeneca plc (LON:AZN) Saphnelo (anifrolumab) 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.3-5
Susan Manzi, MD, MPH, 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.”
Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America, said: “The FDA approval of a subcutaneous administration option for anifrolumab is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “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.”
SLE is amongst the leading causes of death in young women in the US and is more common amongst Asian, Black or Hispanic populations.6,7 While oral corticosteroids are often used to provide relief from SLE symptoms, they are associated with adverse events and do not target the underlying drivers of the disease.8-10 Recent updates to clinical guidelines elevate the importance of treating to target remission or low disease activity and minimising the use of oral corticosteroids.11,12
Subcutaneous administration of Saphnelo is approved in the EU and Japan and under regulatory review in several other countries around the world. Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide, including the US and EU. To date, more than 40,000 patients globally have been treated with Saphnelo.13 Saphnelo IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS criteria for remission.14,15
Financial considerations
AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. Under the agreement, updated in 2025, AstraZeneca will pay BMS a mid-teens royalty for sales in the US.
