Amgen said its investigational drug dazodalibep met the primary endpoint in a late-stage trial, producing a statistically significant and clinically meaningful reduction in Sjogren's disease activity at week 48. Most side effects were reported as mild to moderate, with few treatment discontinuations. Amgen will present detailed data at an upcoming medical meeting; the study is expected to complete in Q4 2026. Sjogren's affects roughly 1% of people worldwide and primarily impacts women.
Amgen’s Experimental Sjogren’s Drug Dazodalibep Hits Primary Endpoint in Late-Stage Trial
The Amgen logo is seen in this illustration taken August 3, 2025. REUTERS/Dado Ruvic/Illustration
Amgen said on Tuesday that its investigational therapy dazodalibep achieved the primary endpoint in a late-stage trial, demonstrating a statistically significant and clinically meaningful reduction in disease activity for patients with Sjogren's disease at week 48.
Trial Findings and Safety
The company reported that most adverse events were mild to moderate and that only a small number of patients discontinued treatment. Detailed efficacy and safety data will be presented by Amgen at an upcoming medical meeting.
About Sjogren's Disease
Sjogren's disease is an autoimmune disorder that attacks the body's moisture-producing glands, causing severe dryness of the eyes, mouth and other areas, and often producing fatigue and chronic pain. The National Institutes of Health estimates the condition affects about 1% of the global population and predominantly affects women.
Context and Next Steps
There are currently no approved treatments for Sjogren's disease in the United States. Novartis and Johnson & Johnson are among other companies developing therapies for the condition. Amgen expects the study to be completed in the fourth quarter of 2026 and will present full trial data at a forthcoming medical meeting.
Reporting: Christy Santhosh in Bengaluru; Editing: Vijay Kishore.
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