Amgen's Dazodalibep Clears Phase 3 Hurdle in Treating Systemic Sjögren's Disease
Amgen's dazodalibep has cleared a major hurdle in its development as a treatment for systemic Sjögren's disease. The company announced that its Phase 3 trial, OASIZ 301, met its primary endpoint in adults with moderate-to-severe systemic Sjögren's disease.
The trial tested dazodalibep against a placebo and found that it produced 'clinically meaningful improvement in systemic disease activity' at Week 48, measured on the ESSDAI scale. This result matches the trial's pre-registered design and is a significant milestone for Amgen's Sjögren's franchise.
The study enrolled 651 participants with moderate-to-severe systemic disease, making it a major step forward in treating this condition. There is currently no treatment approved specifically for systemic Sjögren's disease activity, underscoring the commercial stakes if dazodalibep advances through regulatory review.