AstraZeneca received FDA approval on April 27, 2026 for the SAPHNELO Pen, a once‑weekly autoinjector that allows adult patients with systemic lupus erythematosus (SLE) to self‑administer anifrolumab‑fnia at home.
The SAPHNELO Pen builds on the company’s existing anifrolumab product, which was first approved for intravenous infusion in July 2021 and has already received subcutaneous approval in the European Union and Japan. The new U.S. approval follows the Phase III TULIP‑SC trial, which demonstrated statistically significant improvements in disease activity, including higher BICLA response rates, increased remission rates, and lower disease activity scores compared with placebo.
Anifrolumab works by blocking the type I interferon receptor, thereby reducing the inflammatory pathways that drive lupus. The TULIP‑SC data showed that patients receiving the subcutaneous formulation achieved clinically meaningful reductions in disease activity, supporting the safety and efficacy of the new delivery method.
The autoinjector is expected to improve patient convenience and adherence, potentially expanding the drug’s market reach. By offering a self‑administered option, AstraZeneca can compete more directly with GSK’s Benlysta, which also provides a self‑injectable formulation. Analysts estimate that the SAPHNELO Pen could contribute $1 billion to $3 billion in peak annual sales, and AstraZeneca will pay Bristol‑Myers Squibb a mid‑teens royalty on U.S. sales under the updated licensing agreement.
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.”
Susan Manzi, principal investigator of the TULIP‑SC trial, added, “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.” She also noted that the drug “has been a much‑needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.”
Louise Vetter, President and CEO of the Lupus Foundation of America, commented, “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.”
SAPHNELO is part of AstraZeneca’s immunology and autoimmune disease portfolio, not its oncology division. The approval strengthens the company’s diversification strategy and positions it for growth in the expanding lupus market.
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