WILMINGTON, Del. — AstraZeneca has received U.S. approval for a new self-injectable version of its lupus drug SAPHNELO®, expanding treatment options for patients with systemic lupus erythematosus.
The U.S. Food and Drug Administration cleared the SAPHNELO Pen, a once-weekly autoinjector designed for at-home use in adult patients receiving standard therapy. The approval allows patients to administer the medication subcutaneously, offering an alternative to intravenous infusions.
The decision was based on results from the Phase III TULIP-SC trial, which showed the subcutaneous form significantly reduced disease activity in patients with moderate to severe lupus compared with placebo. The safety profile was consistent with the intravenous version of the drug.
“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,” said Susan Manzi, M.D., MPH, a principal investigator in the study.
Patient advocates also highlighted the added flexibility the new option provides.
“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,” said Louise Vetter, President and Chief Executive Officer of the Lupus Foundation of America.
AstraZeneca said the new delivery method builds on the drug’s existing impact.
“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,” said Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit.
Systemic lupus erythematosus is a chronic autoimmune disease that disproportionately affects women and can lead to serious organ damage. It remains one of the leading causes of death among young women in the United States, particularly among Asian, Black, and Hispanic populations.
SAPHNELO is already approved as an intravenous infusion in more than 70 countries, and the subcutaneous version has been cleared in the European Union and Japan, with additional regulatory reviews ongoing worldwide. AstraZeneca said more than 40,000 patients globally have been treated with the therapy to date.
The company originally acquired global rights to SAPHNELO through a licensing agreement with Medarex in 2004. Under an updated agreement, AstraZeneca pays Bristol-Myers Squibb a mid-teens royalty on U.S. sales.
