WILMINGTON, DE — AstraZeneca said the SAPHNELO Pen has received approval from the U.S. Food and Drug Administration for self-administration in adults with systemic lupus erythematosus receiving standard therapy.
The once-weekly autoinjector allows subcutaneous administration of the lupus treatment outside clinical infusion settings.
The approval was based on results from the Phase III TULIP-SC clinical trial, which showed statistically significant reductions in disease activity among patients with moderate to severe systemic lupus erythematosus compared with placebo, according to the company.
Trial results were published in January in the journal Arthritis & Rheumatology.
Susan Manzi, principal investigator of the TULIP-SC trial and chair of the Allegheny Health Network Medicine Institute, said the autoinjector could improve treatment accessibility and convenience for lupus patients.
“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,” Manzi said.
Lupus Foundation of America President and Chief Executive Officer Louise Vetter said the approval expands treatment options for patients seeking alternatives to infusion-based administration.
AstraZeneca said more than 40,000 patients globally have been treated with SAPHNELO. The intravenous version of the therapy is approved in more than 70 countries, including the United States and European Union markets.
The company said subcutaneous administration of the treatment is already approved in the European Union and Japan and remains under regulatory review in additional countries.
Systemic lupus erythematosus is an autoimmune disease that disproportionately affects women and has higher prevalence rates among Asian, Black, and Hispanic populations, according to the company.
AstraZeneca acquired global rights to SAPHNELO through a licensing agreement with Medarex in 2004. Under an updated agreement, the company pays royalties on U.S. sales to Bristol Myers Squibb.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.