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Nipocalimab Granted FDA Breakthrough Therapy Designation for Sjögren’s Disease

• Nipocalimab, a Johnson & Johnson investigational therapy, has received FDA Breakthrough Therapy designation for moderate-to-severe Sjögren’s disease. • The designation was based on Phase 2 DAHLIAS study results, which showed a 70% improvement in systemic disease activity compared to placebo. • Nipocalimab aims to address the underlying causes of Sjögren’s disease, for which there are currently no approved treatments targeting the root cause. • A Phase 3 study is underway to further evaluate nipocalimab as a novel treatment option for patients with Sjögren’s disease.

Johnson & Johnson's nipocalimab has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe Sjögren’s disease (SjD). This marks a significant advancement as nipocalimab is the first investigational therapy to receive this designation for SjD, a chronic autoantibody disease lacking advanced, targeted treatments.
The FDA's decision was influenced by promising data from the Phase 2 DAHLIAS study. The study demonstrated that patients treated with nipocalimab experienced a greater than 70% improvement in systemic disease activity at Week 24 compared to those receiving a placebo. These findings underscore nipocalimab's potential as a targeted treatment for SjD, a condition characterized by the dysfunction of glands producing saliva and tears, often leading to systemic complications affecting multiple organs.

Clinical Significance of Breakthrough Therapy Designation

The Breakthrough Therapy designation is designed to accelerate the development and review of drugs that demonstrate substantial improvement over existing therapies for serious or life-threatening conditions. This is the second time nipocalimab has received this designation; the first was for the treatment of hemolytic disease of the fetus and newborn earlier in the year.
Terence Rooney, Vice President, Rheumatology, Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine, emphasized the critical need for innovation in SjD treatments. "With no treatments currently approved that may directly address the underlying cause(s) of the disease, innovation is critically needed to improve patient outcomes in Sjögren’s disease," he stated.

Ongoing Evaluation and Future Directions

Johnson & Johnson is currently conducting a Phase 3 study to further assess the efficacy and safety of nipocalimab, building upon the Phase 2 results presented at the European Alliance of Associations for Rheumatology Congress. This ongoing research aims to provide a novel treatment option for SjD patients, who often face significant health challenges and risks associated with the disease.
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Reference News

[1]
FDA Grants Breakthrough Therapy Designation to Johnson & Johnson's Nipocalimab ... - MyChesCo
mychesco.com · Nov 18, 2024

Johnson & Johnson's nipocalimab receives FDA Breakthrough Therapy designation for treating moderate-to-severe Sjögren’s ...

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