Amgen's dazodalibep succeeds in Phase 3 trial for Sjögren's disease

Amgen Inc. announced on September 22, 2026, that its experimental drug dazodalibep met the primary goal of a Phase 3 trial for moderate-to-severe Sjögren’s disease, showing statistically significant improvement at 48 weeks. Sjögren’s is a chronic autoimmune disorder affecting up to 4 million Americans that currently has no FDA-approved treatments. The positive results bolster Amgen's position against competitor Novartis, which is awaiting an FDA decision on its own Sjögren’s therapy, ianalumab.

Dazodalibep Phase 3 trial results

• ▪The most common adverse events in Amgen's Phase 3 trial of dazodalibep for moderate-to-severe Sjögren's disease were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, which were generally mild to moderate
• ▪Amgen's experimental drug dazodalibep met its primary goal in a Phase 3 trial for moderate-to-severe Sjögren's disease, showing statistically significant and clinically meaningful improvement as early as week 4, sustained through week 48
• ▪Amgen withheld specific numerical results from the dazodalibep Phase 3 trial for Sjögren's disease on September 22, 2026, reserving the detailed data for presentation at a future medical meeting
• ▪Lead investigator Dr. Ghaith Noaiseh stated on September 22, 2026, that the preliminary dazodalibep Phase 3 trial results represent an important advance for the field of Sjögren's disease

Second Phase 3 trial of dazodalibep

• ▪William Blair analyst Matt Phipps stated on September 22, 2026, that Amgen will likely require two Phase 3 studies to support FDA approval of dazodalibep for Sjögren's disease
• ▪Amgen is conducting a second Phase 3 clinical trial evaluating dazodalibep in Sjögren's disease patients characterized by high symptom burden and low systemic disease activity
• ▪Amgen stated on September 22, 2026, that its second Phase 3 clinical trial for dazodalibep could be completed in the fourth quarter of 2026

Analyst perspective on drug development

• ▪William Blair analyst Matt Phipps noted on September 22, 2026, that Sjögren's disease drug development is historically challenging and high risk due to high placebo response rates and variable disease presentation
• ▪William Blair analyst Matt Phipps noted on September 22, 2026, that Amgen's positive dazodalibep Phase 3 readout potentially supports its novel patient segmentation strategy of dividing Sjögren's disease into separate systemic and symptomatic disease buckets

Sjögren's disease overview

• ▪Sjögren's disease is a chronic autoimmune disorder that attacks tear ducts and salivary glands, leaving patients with dry eyes and dry mouth
• ▪According to the Sjögren's Foundation, up to 4 million Americans have Sjögren's disease, making it the second most common rheumatic autoimmune condition in the United States

Debatable claims

• ▪Pharmaceutical companies should release full numerical data when announcing clinical trial successes
• ▪The FDA should require multiple Phase 3 trials to approve Sjögren's disease treatments