Nipocalimab Is Granted Fast Track Designation for Treatment of Patients With Sjögren’s Disease

Nipocalimab (Johnson & Johnson), a novel investigational agent, was granted a fast track designation from the FDA for treatment of adult patients with moderate-to-severe Sjögren’s disease (SjD). The decision marks nipocalimab as the first and only therapy to address the underlying mechanism of SjD.

Sjögren’s syndrome written on sticky note| Image Credit: © yahrir - stock.adobe.com

“This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren’s disease, a serious and debilitating condition. We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community,” said Katie Abouzahr, MD, vice president, Autoantibody Portfolio and Maternal Fetal Disease Area Leader, Johnson & Johnson Innovative Medicine, in a news release.¹

SjD is one of the most common chronic autoimmune diseases that is estimated to affect 4 million individuals around the world. Despite its prevalence, there are no approved therapeutic options that treat the disease’s underlying systemic nature. Treatment for SjD is focused on symptom management, which can include prescription eye drops for eye inflammation, agents that increase saliva production, as well as other therapies depending on an individual’s specific complications. More than half of SjD patients suffer from a moderate to severe form of the illness, and the disease burden can be comparable to that of systemic lupus erythematosus or rheumatoid arthritis.²

SjD first targets the glands that help produce tears and saliva but can affect other parts of the body, including the joints, thyroid, kidneys, liver, lungs, skin, and nerves. It is primarily diagnosed in individuals ages 40 and older and disproportionately affects women. Patients with rheumatic disease are also more likely to have SjD.²

The fast track designation is based on results from the phase 2 multicenter, randomized, placebo-controlled double-blind, dose-ranging DAHLIAS study (NCT04968912) evaluating nipocalimab in participants with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. The trial randomly assigned adults between the ages of 18 and 75 to receive their intravenous nipocalimab at 5 or 15 mg per kg or placebo every 2 weeks through week 22. The primary end point of the study was a change in baseline in the Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index score at week 24.^1,3

At week 24, the study met its primary end point in the group that received nipocalimab at a dosage of 15 mg per kg, showing over 70% relative average improvement in systemic disease. Additionally, nipocalimab led to immunoglobulin G reductions of over 77%.¹

The FDA’s fast track designation for nipocalimab represents a significant milestone in the pursuit of targeted treatments for SjD. With promising results from the DAHLIAS study demonstrating meaningful improvements in systemic disease activity, nipocalimab could offer new hope for patients with moderate-to-severe SjD. As clinical development advances, the designation may help expedite the availability of this novel therapy, potentially addressing a critical unmet need for the millions affected by this debilitating autoimmune disorder.

REFERENCES

1. Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now received Fast Track designation. Johnson&Johnson. March 18, 2025. Accessed March 20, 2025. https://www.jnj.com/media-center/press-releases/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-received-fast-track-designation

2. Sjogren's syndrome. Mayo Clinic. August 2, 2022. Accessed March 20, 2025. https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216#:~:text=Overview,as%20rheumatoid%20arthritis%20and%20lupus

3. A study of nipocalimab in adults with primary Sjogren's syndrome (pSS). Updated March 4, 2025. Accessed March 20, 2025. https://clinicaltrials.gov/study/NCT04968912