Amgen announced that its experimental drug dazodalibep met the primary endpoint in a phase 3 trial for Sjögren's disease, showing statistically significant and clinically meaningful improvement in disease activity at week 48. Sjögren's disease is a chronic autoimmune condition that attacks moisture-producing glands, causing debilitating dryness of the eyes, mouth, and other parts of the body, along with fatigue and chronic pain.

The safety profile looked encouraging — most adverse events were mild to moderate, with very few patients discontinuing treatment. Amgen plans to share full trial data at an upcoming medical meeting, with the trial expected to wrap up in Q4 2026. Competitors Novartis and Johnson & Johnson are also racing to develop treatments for this condition.

By the Numbers:

• ~1% of the global population is affected by Sjögren's disease, predominantly women
• Week 48 was the primary endpoint timeframe for measuring disease activity reduction
• Adverse events were mostly mild to moderate, with few discontinuations

Why it matters: Sjögren's disease currently has no approved treatments in the US, leaving millions of patients relying solely on symptom management. A successful phase 3 result for dazodalibep could mark a turning point, potentially offering the first disease-modifying therapy for this underserved patient population.