Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis.
The readout covers dazodalibep, a fusion protein acquired in the Horizon Therapeutics takeover. Amgen reported a phase 3 win in September and shared data in an American College of Rheumatology (ACR) Convergence 2026 abstract last month. TD Cowen analysts led with “dazo dazzles” in their Oct. 27 note to investors about the data and talked up Amgen’s prospects of meeting and potentially exceeding their $1.8 billion peak sales forecast.
Amgen released more data on its CD40L antagonist in systemic Sjögren’s in its ACR presentation. At Week 48, 70% of patients in the monthly dosing cohort had at least a three-point improvement on the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), compared with 52.8% of people on placebo.
Almost 58% of patients on monthly dazodalibep had at least a five-point improvement in ESSDAI, versus 38% of people on placebo. The seven-point improvement figures were 53.3% and 34.8% on monthly dazodalibep and placebo, respectively.
The results reflect broad improvements across the domains assessed by the ESSDAI tool. Responses were at least 10 percentage points higher in the monthly cohort than the placebo arm across constitutional, lymphadenopathy, glandular, cutaneous and biological domains. The articular and hematological results also favored dazodalibep, although the gap over placebo was smaller.
Dazodalibep beat placebo on the Sjögren’s Tool for Assessing Response (STAR), a composite score for evaluating the effect of a treatment. At Week 48, 70.5% of patients on monthly dazodalibep were STAR responders, compared with 42% of people on placebo.
Amgen could compete for the Sjögren’s market with Novartis, which reported phase 3 data on ianalumab in the indication one year ago. Novartis shared updated Week 108 data this week at the ACR Convergence, which showed that ESSDAI reductions deepened over time. Adjusting for placebo, Amgen reported numerically larger Week 48 reductions in ESSDAI than Novartis.
Even so, Guggenheim Securities analysts predicted in a note to investors this week that the unmet need in Sjögren’s could give ianalumab “a strong launch base.” Amgen will target the same patients, and Novartis “expects some cycling between therapies, [especially] given disease heterogeneity,” Guggenheim analysts said.
The breadth of the opportunity open to Amgen is still coming into focus. Notably, the company has yet to share phase 3 data on the drug candidate in symptomatic Sjögren’s disease. Data are due this year.
On an earnings call last week, Jay Bradner, M.D., executive vice president of R&D at Amgen, noted the difficulty of defining what the success of the systemic trial means for the symptomatic study because of differences between the patient populations. TD Cowen analysts were less reticent, saying that the data in the ACR abstract raised their confidence in the upcoming readout.
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