APR 27 2026
AstraZeneca — Saphnelo (anifrolumab) $AZN
for systemic lupus erythematosus
FDA approved AstraZeneca's Saphnelo Pen autoinjector for once-weekly subcutaneous self-administration in adult SLE patients.
About
Lupus is an autoimmune disease in which the immune system mistakenly attacks healthy tissue throughout the body, causing painful swollen joints, fever, chest pain, hair loss, fatigue, and a facial rash, with symptoms that flare and then fade. Saphnelo (anifrolumab) is a lab-made antibody that binds to and blocks a receptor for type I interferon, a signaling protein that drives the immune attack in lupus. By blocking that signal, the drug may calm the overactive immune response and reduce the frequency and severity of flares.
Pivotal trial
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Saphnelo
- Study finds Anifrolumab may help restore overall immune health in people with systemic lupus erythematosus - Lupus Foundation of America
- Four-Year Data Confirm Anifrolumab Efficacy in Lupus - MedPage Today
- SAPHNELO shows strong sales growth and market p... - Pluang
- Weekly Buzz: FDA Okays Saphnelo Pen, EC Clears Acromegaly Drug, SNGX Slumps, LGND Snaps Up XOMA - RTTNews
- FDA approves Saphnelo Pen for at-home lupus treatment - Lupus News Today