Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome

Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a difficult autoimmune disease with no disease-modifying therapies.

The company said the treatment produced a statistically significant and clinically meaningful improvement on a widely used disease activity score after 48 weeks, with benefits observed as early as four weeks and sustained throughout the study. Safety data showed no imbalance in serious events such as blood clots or opportunistic infections, and side effects were generally mild to moderate.

The positive readout lifted Amgen’s share price by up to 5% on the day of the announcement, underscoring investor interest in a potential first-in-class therapy for a condition that has long eluded effective treatment.