- In October 2022, Biogen Inc. announced that the first patient had been dosed in AMETHYST, a global clinical trial. The Phase 2/3 study aims to compare litifilimab (BIIB059), a novel humanized IgG1 monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2), with a placebo in participants with cutaneous lupus erythematosus (CLE). This study marks a significant step forward in investigating new treatments for this form of lupus
- In August 2021, AstraZeneca's Saphnelo (anifrolumab-fnia) gained approval in the U.S. for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are already on standard therapy. This approval marks a major breakthrough in treatment options for patients with this complex autoimmune disease. By targeting specific immune system pathways, Saphnelo offers a novel approach to better manage SLE and potentially improve patient outcomes
- In December 2020, GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) approved BENLYSTA (belimumab) for treating adult patients with active lupus nephritis (LN) who are already undergoing standard therapy. Lupus nephritis, a severe kidney inflammation caused by systemic lupus erythematosus (SLE), can progress to end-stage kidney disease, necessitating dialysis or a transplant. This approval expands BENLYSTA’s indication in the U.S., making it available for both SLE and LN treatment in intravenous and subcutaneous formulations
