AstraZeneca (LSE:AZN) has won FDA approval to allow self-administration of Saphnelo (anifrolumab) via a once‑weekly 120mg autoinjector, the Saphnelo Pen, for adults with systemic lupus erythematosus receiving standard therapy.
The approval was based on the Phase III TULIP‑SC trial, which randomised 367 participants and showed a statistically significant and clinically meaningful reduction in disease activity versus placebo at week 52, with full results published in Arthritis & Rheumatology in January 2026.
The safety profile with subcutaneous dosing was consistent with the known intravenous profile, and the TULIP‑SC programme reported clinically meaningful secondary outcomes including steroid tapering to ≤7.5 mg/day, earlier BICLA responses, and numerically delayed time to first flare.
Saphnelo will be available as the pre-filled Saphnelo Pen or syringe, adding a self‑administration option to the IV infusion launched in 2021, and subcutaneous use is already approved in the EU and Japan with more than 40,000 patients treated globally with Saphnelo IV to date.
Under a 2025 update to AstraZeneca’s 2004 licence, the group will pay Bristol‑Myers Squibb a mid‑teens royalty on US sales of Saphnelo.
“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, BioPharmaceuticals Business Unit, AstraZeneca.
Saphnelo continues to be evaluated in Phase III studies in cutaneous lupus, myositis, systemic sclerosis and lupus nephritis and subcutaneous regulatory reviews are ongoing in other countries.
