Amgen Reports Phase 3 Win for Sjögren's Drug
Dazodalibep beat placebo on key disease-activity measures in a phase 3 trial, with detailed results presented at ACR Convergence 2026.
Updated on Nov. 11, 2026 in Biotech
Amgen reported a phase 3 win for dazodalibep in systemic Sjögren's disease, releasing detailed data at the ACR Convergence 2026 meeting. At Week 48, a larger share of patients on the monthly dazodalibep cohort showed improvement on the ESSDAI disease-activity tool than patients on placebo.
Why it matters
Sjögren's disease is a chronic autoimmune condition with limited treatment options, and a positive phase 3 result moves dazodalibep closer to potential approval. Novartis, which shared updated data for its competing drug ianalumab at the same meeting, expects patients may cycle between therapies given the disease's variability.
At Week 48, 70% of monthly dazodalibep patients achieved at least a three-point ESSDAI improvement versus 52.8% on placebo, and 70.5% were STAR responders versus 42% on placebo. The gains held across five- and seven-point ESSDAI thresholds, though symptomatic-disease results remain unreported.
The players
Amgen
Amgen is a large American biotechnology company that developed and reported the phase 3 results for dazodalibep.
Novartis
Novartis is a Swiss pharmaceutical company that shared updated phase 3 data for its competing Sjögren's drug ianalumab at the same meeting.
The details
The data came from a phase 3 study comparing monthly dazodalibep with placebo, with Week 48 as the primary assessment point. Improvements were reported across the domains measured by the ESSDAI tool, and dazodalibep is a fusion protein that Amgen acquired through its Horizon Therapeutics takeover.
Timeline
September 2026: Amgen reported the phase 3 win for dazodalibep.
October 27, 2026: TD Cowen analysts issued a note on the dazodalibep data.
Week 48: Primary ESSDAI and STAR endpoint assessment timepoint.
Week 108: Novartis shared updated ianalumab data at the ACR meeting.
Later in 2026: Amgen's phase 3 data in symptomatic Sjögren's disease are due.
Market Landscape
Amgen and Novartis are racing to bring the first targeted therapies for systemic Sjögren's disease to market, and both are presenting late-stage data at the same rheumatology meeting. TD Cowen analysts forecast dazodalibep peak sales could meet or potentially exceed $1.8 billion, signaling how commercially significant the indication has become.
If approved, dazodalibep would give patients with systemic Sjögren's disease a new targeted option for managing dryness, fatigue, and systemic symptoms. Patients and clinicians should watch for regulatory filings and the symptomatic-disease data expected later this year before drawing conclusions about real-world benefit.
The takeaway
Dazodalibep's phase 3 results show a clear separation from placebo on multiple disease-activity measures, but the symptomatic-disease data and long-term durability will determine whether it becomes a standard therapy. Readers should follow the pending phase 3 readouts before treating the drug as established.
What happens next
Amgen's phase 3 data in symptomatic Sjögren's disease are expected later this year.
Further reading
For more on the drug development pipeline behind these results, explore our Biotech coverage.
