Amgen's (Nasdaq: AMGN) dazodalibep, a CD40 ligand (CD40L) antagonist fusion protein, met its primary endpoint in a Phase III trial of systemic Sjögren's disease, delivering statistically significant and clinically meaningful improvement in disease activity at Week 48. Amgen reported the topline results on September 22, 2026, and said detailed data will be presented at an upcoming medical meeting.
The OASIZ 301 study enrolled approximately 621 adults with moderate-to-severe systemic Sjögren's disease, defined by a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of 5 or above. The primary endpoint was change from baseline in ESSDAI at Week 48. Amgen said improvements were observed as early as Week 4 and were sustained through Week 48. No numerical results — mean changes, hazard ratios, or p-values — were disclosed in the topline release.
Dazodalibep blocks the CD40L–CD40 co-stimulatory interaction between T cells and B cells, disrupting the upstream immune activation that drives Sjögren's disease pathology. This mechanism distinguishes it from pipeline competitors targeting downstream B cell biology: Novartis's ianalumab depletes B cells via BAFF-R blockade, and Johnson & Johnson's nipocalimab reduces circulating IgG autoantibodies by inhibiting the neonatal Fc receptor (FcRn). Novartis received FDA Breakthrough Therapy Designation for ianalumab in Sjögren's disease in January 2026 and has been reported to be targeting a US launch in the second half of 2026, making it the most advanced competitor on a regulatory timeline. China-based RemeGen's telitacicept, a dual BAFF/APRIL inhibitor, received China NMPA approval for Sjögren's disease in June 2026, but holds no FDA or EMA approval in this indication.
The only currently approved therapies for Sjögren's disease — pilocarpine and cevimeline — are oral muscarinic agonists that address dry mouth symptoms and have no effect on systemic disease activity.