Amgen Announces Breakthrough Results for Dazodalibep in Moderate-to-Severe Sjögren's Disease

Amgen has announced positive topline results from its Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren's disease and moderate-to-severe systemic disease activity.

The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).

Sjögren's disease is a complex autoimmune condition that affects multiple systems in the body, with symptoms including dryness, fatigue, pain, and an increased risk of lymphoma.

There are currently no FDA-approved medicines for Sjögren's disease, making dazodalibep a potential breakthrough treatment option for people living with this debilitating condition.