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# Sjögren's Went Decades Without an Approved Drug. Two Are Almost Here.
- URL: https://bioweek.com/sjogrens-went-decades-without-an-approved-drug-two-are-almost-here/
- Published: 2026-11-12T12:21:22.000Z
- Updated: 2026-11-12T12:21:22.000Z
- Description: After decades with no FDA-approved therapy, Amgen and Novartis both have Phase 3 winners in Sjögren's disease. The harder question is whether either can beat the symptom patients feel most: dryness.
- Author: BioWeek
- Tags: Pipeline

Sjögren's disease affects an estimated 4 million people in the United States, according to the Sjögren's [Foundation](https://sjogrens.org/news/2026/world-sjogrens-day-highlights-the-need-for-greater-awareness-of-sjogrens-disease?ref=bioweek.com), a systemic autoimmune condition marked by dryness, fatigue, pain and, for some, organ involvement. Not one of them has an FDA-approved treatment. The disease has gone decades with nothing cleared for it, and Novartis [notes](https://www.novartis.com/news/media-releases/novartis-ianalumab-two-year-data-acr-show-further-improvements-sjogrens-disease-activity?ref=bioweek.com) there are no approved targeted therapy options outside China. Two companies now hold Phase 3 wins in the indication, roughly a year apart, and both are headed for regulatory decisions.

### Amgen's trial delivers on both fronts

On Nov 11, Amgen [announced](https://www.amgen.com/newsroom/press-releases/2026/11/amgen-announces-positive-phase-3-results-for-dazodalibep-in-sjgrens-disease?ref=bioweek.com) results from the Phase 3 OASIZ-301 study of dazodalibep, which the company describes as the only global Phase 3 trial to show clinically meaningful improvements in both systemic disease activity and symptoms in Sjögren's. The data were presented at ACR Convergence 2026.

Both dosing regimens met the primary endpoint at Week 48 on ESSDAI, a measure of disease activity. The 1500 mg every-4-weeks regimen, tested in 217 patients, cut the least-squares mean ESSDAI score by 5.6 points versus 3.8 for placebo, a 1.8 point difference with adjusted p below 0.001\. The 3000 mg every-12-weeks arm, also 217 patients, showed 5.2 versus 3.8, a 1.4 point difference with adjusted p of 0.010\. Mean baseline ESSDAI was 10.2, and the separation appeared as early as Week 4 and held through Week 48.

The depth numbers show how far patients moved. At Week 48, 70 percent of monthly-dose patients had at least a 3 point ESSDAI improvement versus 52.8 percent on placebo, about 58 percent reached at least 5 points versus 38 percent, and 53.3 percent reached at least 7 points versus 34.8 percent, per ACR data [reported](https://www.fiercebiotech.com/biotech/amgen-builds-sjogrens-case-detailed-phase-3-data-ahead-novartis-showdown?ref=bioweek.com) by Fierce Biotech. On the STAR composite response measure, 70.5 percent of monthly patients were responders against 42 percent on placebo.

### The dryness signal is the difference

What sets the Amgen readout apart is the patient-reported data. The monthly regimen produced a placebo-adjusted difference of 1.17 points on the ESSPRI dryness domain and 0.93 points on the DASPRI dryness domain, both with adjusted p values below 0.001\. Mean improvement in total ESSPRI exceeded 1.5 points with both regimens. In a disease defined by dryness, that patient-level signal is what separates these two readouts.

Dazodalibep is a CD40L antagonist fusion protein that came to Amgen through its acquisition of Horizon Therapeutics. Jay Bradner, Amgen's research head, said the results strengthen the clinical rationale for targeting CD40L-mediated immune signaling, and the company plans a broader Phase 3 program. Analysts at TD Cowen have put peak sales for dazodalibep in Sjögren's at 1.8 billion dollars.

### Ianalumab won the activity endpoint and missed the symptom one

Novartis got there first with a different mechanism. Ianalumab is an IgG1 antibody combining B-cell depletion through antibody-dependent cellular cytotoxicity with blockade of the B-cell activating factor receptor. In the NEPTUNUS-1 trial, 275 patients randomized to 300 mg monthly or placebo, the Week 48 ESSDAI between-group difference was 1.3 points with a p value of 0.0496\. In NEPTUNUS-2, 504 randomized, it was 1.0 points with p equal to 0.04\. Novartis called the two trials the first global Phase 3 studies to demonstrate a statistically significant reduction in Sjögren's disease activity.

The symptom endpoints did not follow. Per the [publication](https://doi.org/10.1056/nejmoa2601088?ref=bioweek.com) in the New England Journal of Medicine, no significant differences were seen in ESSDAI response rates or in the symptom scores SSSD or ESSPRI. Serious adverse events ran similar to placebo; injection-site and injection-related reactions were more common. Dryness is the endpoint ianalumab has yet to answer.

### Two years in, and a decision this year

At ACR on Nov 10, Novartis presented two-year extension data. In patients staying on monthly ianalumab, mean ESSDAI reduction deepened to 7.5 points from core-study baseline, against 6.5 for placebo switchers. Low disease activity rose from 57.1 percent at Week 48 to 65.1 percent at Week 108 in the continuous group, and salivary-flow improvements were maintained through Week 96 in patients whose baseline flow exceeded 0.4 mL per minute. Adverse event rates stayed comparable through Week 204 with no new safety findings. The drug is under review in multiple countries, with a US FDA decision expected this year.

Adjusting for placebo, Amgen's Week 48 ESSDAI reductions were numerically larger than what Novartis reported for ianalumab, and dazodalibep hit patient-reported dryness while ianalumab's symptom endpoints were not significant in NEPTUNUS. These are cross-trial comparisons with different populations and designs, so numerically larger falls well short of proven superior. Guggenheim analysts expect ianalumab to still have a strong launch base given the unmet need, and Novartis itself anticipates some cycling between therapies given how heterogeneous the disease is.

The harder test may still be ahead. Amgen's Phase 3 program also includes a trial in symptomatic Sjögren's patients with data due this year, and Bradner has acknowledged the difficulty of defining what success in the systemic trial means for that study, because the patient populations differ. Approval will settle who reaches the market first. Whether either drug moves the symptom patients feel every day is the readout that will shape the field.