Summary
SLE is a chronic autoimmune disease affecting multiple organs, with ~936K diagnosed cases across the 7MM in 2025 and expected growth by 2036.
BENLYSTA (belimumab, GSK) remains the cornerstone biologic, targeting BLyS to reduce autoreactive B cells; it expanded into lupus nephritis, pediatrics, and multiple formulations (IV and SC).
SAPHNELO (anifrolumab, AstraZeneca), approved in 2021, is the second biologic targeting the interferon pathway.
The SLE pipeline is highly active, with 140+ therapies across 120+ companies, including biologics, oral small molecules, and advanced modalities like CAR-T therapies.
Promising drugs under development inclu...