Amgen's dazodalibep clears phase 3 Sjögren's trial

Overview

Updated 1 hour ago

Sjögren's disease has no approved treatment in the US. Amgen just moved a step closer to ending that.

On September 22, Amgen said dazodalibep, a drug it gained through the $28 billion Horizon Therapeutics acquisition, met the main goal of a phase 3 trial. Patients with moderate-to-severe systemic disease showed meaningful improvement at 48 weeks, measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Benefits appeared by week 4 and held through week 48.

The result sets up a race with Novartis, whose rival drug ianalumab is under FDA review with a decision expected in coming months. A second Amgen trial, OASIZ 303, in patients with a high symptom burden but low systemic disease, is due in the fourth quarter of 2026.

Why it matters

Millions of Sjögren's patients have no approved therapy; this trial puts the first one, and a race to file it, within reach.

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Key Indicators

FDA-approved Sjögren's treatments in the US

No drug has ever won US approval for Sjögren's disease.

~621

Patients in the OASIZ 301 trial

Adults with moderate-to-severe systemic Sjögren's disease activity, measured by ESSDAI of 5 or higher.

$28.3B

Amgen's acquisition of Horizon Therapeutics

Closed October 2023; brought dazodalibep into Amgen's pipeline.

48 weeks

Primary endpoint timepoint

Improvement on ESSDAI was measured at week 48, with effects seen from week 4.

2.2 points

Phase 2 ESSDAI treatment advantage

At week 24 of the 2022 phase 2 trial, dazodalibep beat placebo by 2.2 points (6.3 vs 4.1 reduction, p=0.017).

Voices

Curated perspectives — historical figures and your fellow readers.

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People Involved

Matt Phipps

Senior research analyst at William Blair

Covering Amgen's Sjögren's program

Organizations Involved

Amgen Inc.

Biopharmaceutical company

Sponsor of the dazodalibep phase 3 program

Global biopharmaceutical company headquartered in Thousand Oaks, California.

Horizon Therapeutics

Biotech company (acquired by Amgen)

Original developer of dazodalibep

Ireland-headquartered biotech that developed dazodalibep through phase 2 before Amgen acquired it.

Novartis Pharmaceuticals

Pharmaceutical company

Rival with ianalumab under FDA review

Swiss pharmaceutical company developing ianalumab, an antibody targeting B cells in Sjögren's disease.

Timeline

September 2022 September 2026

4 events Latest: Today

Tap a bar to jump to that date

September 2026
OASIZ 301 phase 3 trial succeeds
Today Clinical trial

Amgen reports dazodalibep met its primary endpoint: significant ESSDAI improvement at week 48 in moderate-to-severe systemic Sjögren's, with effects seen from week 4.
Today
October 2023
Amgen closes Horizon acquisition
Acquisition

Horizon Therapeutics became part of Amgen for $28.3 billion, completing the largest deal in Amgen's history.
October 6th, 2023
December 2022
Amgen agrees to buy Horizon for $28.3 billion
Acquisition

The deal brought dazodalibep and Horizon's autoimmune pipeline into Amgen's portfolio.
December 12th, 2022
September 2022
Horizon's phase 2 trial of dazodalibep hits primary endpoint
Clinical trial

In Sjögren's patients with moderate-to-high systemic disease activity, dazodalibep cut ESSDAI by 6.3 points versus 4.1 for placebo at week 24 (p=0.017).
September 12th, 2022

Scenarios

FDA approves Amgen's dazodalibep as first Sjögren's treatment

Possible Resolves by Q2 2028

Discussed by: William Blair analyst Matt Phipps; Amgen press release

OASIZ 301 succeeded in systemic patients. Phipps expects Amgen to need a second positive study, OASIZ 303 in high-symptom patients, before filing. If that reads out positive in Q4 2026, Amgen would file and could win the first FDA-approved Sjögren's drug.

Novartis's ianalumab becomes the first approved Sjögren's therapy

Possible Resolves by Q1 2027

Discussed by: MedCity News; Reuters

Ianalumab targets B cells and showed significant results in two phase 3 studies presented at the American College of Rheumatology congress in fall 2025. With an FDA decision expected in the coming months, Novartis could win approval before Amgen files for dazodalibep.

OASIZ 303 misses, Amgen's broad approval path narrows

Possible Resolves by End of 2026

Discussed by: William Blair's Matt Phipps (expects two positive studies for broad approval)

The companion trial in patients with high symptom burden and low systemic disease could fail to differentiate from placebo. Amgen would then face a choice: file for the systemic population only, or run another study. That would push any dazodalibep approval past Novartis's timeline.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

February 2006

Rituximab, a cancer drug, wins RA approval (2006)

Rituxan (rituximab), an antibody that depletes B cells, was approved for rheumatoid arthritis a decade after its lymphoma approval. It was the first B-cell-targeted therapy for RA.

Then

Rituximab expanded into a range of autoimmune indications and validated immune-cell targeting.

Now

Showed that immune-cell-targeting drugs can span diseases, a logic that underpins both ianalumab's B-cell approach and dazodalibep's CD40L blockade.

Why this matters now

Both current Sjögren's candidates use immune-cell-targeting mechanisms that first proved out in other diseases.

March 2011

FDA approves Benlysta, first new lupus drug in 56 years (2011)

GlaxoSmithKline's Benlysta (belimumab) won FDA approval for systemic lupus erythematosus, the first new treatment for the disease since 1955. The milestone came after decades of failed lupus trials across the industry.

Then

Benlysta sales built slowly but created a new commercial category in autoimmune disease.

Now

Proved that a systemic autoimmune disease with decades of failures could yield an approved therapy, resetting expectations for other autoimmune conditions.

Why this matters now

Like lupus before 2011, Sjögren's has no approved therapy; dazodalibep and ianalumab are racing to repeat the Benlysta milestone.