AstraZeneca’s Saphnelo has been approved in the US for self‑administration as a once‑weekly autoinjector, the Saphnelo Pen, for adults with systemic lupus erythematosus receiving standard therapy.
The decision by the FDA is based on results from the phase 3 TULIP‑SC trial, which showed that subcutaneous administration led to a statistically significant and clinically meaningful reduction in disease activity compared with placebo in patients with moderate to severe disease.
The safety profile observed in the trial was consistent with the known clinical profile of Saphnelo when given as an intravenous infusion.
Susan Manzi, chair of the Allegheny Health Network Medicine 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 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.”
Ruud Dobber, Executive Vice President of AstraZeneca’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.”
Subcutaneous Saphnelo is already approved in the EU and Japan and is under review in several other countries. The IV formulation is approved in more than 70 countries, with more than 40,000 patients treated globally.
