Amgen’s experimental drug dazodalibep met the main goal in a late-stage Sjögren’s trial: after 48 weeks, patients with moderate-to-severe disease activity showed statistically significant, clinically meaningful improvement.
Most adverse events were mild to moderate, and few patients stopped treatment. Sjögren’s affects about 1% of the global population and has no approved treatment in the U.S. Amgen plans to present more detailed results at an upcoming medical meeting. Reuters reported that several investor-relevant details have not been disclosed, and the findings still need comparison with Novartis’ ianalumab. Results from a separate study, OASIZ 303, are expected in Q4 2026. William Blair analyst Matt Phipps said two positive late-stage studies would likely be needed for FDA approval.
Novartis and Johnson & Johnson are also developing Sjögren’s treatments, so dazodalibep would face competition if it advances. Amgen expects Prolia sales to decline more rapidly in 2026 after U.S. patent expirations and multiple biosimilar launches; the drug generated $4.41 billion in 2025.
