Global pharma giant AstraZeneca has secured US FDA approval for a new self-injection version of its lupus drug Saphnelo (anifrolumab), marking a significant step forward in how systemic lupus erythematosus (SLE) is treated.
The regulator has cleared the Saphnelo Pen, a once-weekly autoinjector that allows adult patients to administer the treatment at home alongside standard therapy, removing the need for hospital-based infusions.
The approval was driven by data from the Phase III TULIP-SC trial, which demonstrated that subcutaneous (SC) administration of Saphnelo delivered a statistically significant and clinically meaningful reduction in disease activity compared with placebo in patients with moderate to severe SLE on standard therapy.
Importantly, the safety profile of the injectable formulation remained consistent with the established intravenous (IV) version of the drug.
Susan Manzi, principal investigator of the TULIP-SC trial, called the decision a meaningful advance for patients, saying: “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.”
Patient advocates also welcomed the move.
Louise Vetter, President and CEO of the 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.”
From AstraZeneca’s side, executives framed the approval as an expansion of an already widely used therapy.
Ruud Dobber, Executive Vice President of the company’s BioPharmaceuticals Business Unit, 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 remains a serious autoimmune disease and is among the leading causes of death in young women in the US. It disproportionately affects Asian, Black, and Hispanic populations.
