The U.S. Food and Drug Administration just granted approval for a self-administered, once-weekly autoinjector of Saphenlo (anifrolumab), for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
The decision was based on TULIP-SC Phase 3 trial results, which showed a statistically significant and clinically meaningful reduction in disease activity for participants with moderate to severe SLE while receiving standard therapy.
Originally approved in 2021 as an intravenous infusion, anifrolumab is the first type I interferon receptor antagonist, which works by blocking immune system molecules called type I interferons that are one of the main factors that leads to tissue damage and disease symptoms. Significant seminal research in interferons originally funded by the Lupus Research Alliance galvanized research into the molecules’ role in the disease.
Tags: Saphnelo Pen, anifrolumab, AstraZeneca, Saphnelo