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Nipocalimab Granted FDA Breakthrough Therapy Designation for Sjögren's Disease

• The FDA granted Breakthrough Therapy Designation to nipocalimab for moderate-to-severe Sjögren's Disease, an autoantibody disease lacking approved advanced treatments. • This marks the second BTD for nipocalimab, previously recognized for its potential in treating alloimmunized pregnant individuals at high risk of HDFN. • Phase 2 DAHLIAS study data supports the BTD, showcasing positive results for nipocalimab as a targeted therapy in Sjögren's Disease. • A Phase 3 study is underway to further evaluate nipocalimab's efficacy and safety in treating adults with moderate-to-severe Sjögren's Disease.

Johnson & Johnson's nipocalimab has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe Sjögren's disease (SjD). This designation aims to expedite the development and review of nipocalimab, an investigational FcRn blocker, for this debilitating autoimmune condition affecting millions. Sjögren's disease, characterized by chronic dryness and systemic complications, currently lacks approved advanced therapies, highlighting a significant unmet medical need.
The BTD is supported by data from the Phase 2 DAHLIAS study, which evaluated the efficacy and safety of nipocalimab in adult patients with moderate-to-severe SjD. The results, presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress, demonstrated the first positive outcomes for an investigational FcRn blocker as a potential targeted therapy in SjD. The FDA grants BTD to therapies intended to treat serious conditions, where preliminary clinical evidence indicates substantial improvement over existing treatments.

Clinical Significance of Nipocalimab in Sjögren's Disease

Sjögren's disease primarily affects the glands producing saliva and tears, leading to dryness, fatigue, and pain. However, extraglandular manifestations are common, impacting multiple organ systems, including joints, lungs, kidneys, and the nervous system. Patients with SjD face a significantly elevated risk of developing B-cell lymphomas, up to 20 times higher than the general population. Moreover, those with high disease activity across multiple organ systems have a five-fold increased mortality risk.
Nipocalimab's BTD represents a crucial step forward, as it is the only investigational therapy to receive this designation for SjD. This is the second BTD granted to nipocalimab; the first was in February for treating alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).

Ongoing Research and Future Directions

A Phase 3 study is currently underway to further assess the efficacy and safety of nipocalimab in treating adults with moderate-to-severe Sjögren's disease. This trial will provide more comprehensive data on the drug's potential to address the unmet needs of patients suffering from this chronic condition. The Breakthrough Therapy designation should help expedite the development and regulatory review of this potential new therapy.
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Reference News

[1]
Johnson & Johnson Announces U.S. Food and Drug Administration Grants Nipocalimab ...
marketscreener.com · Nov 12, 2024

Johnson & Johnson announced FDA's Breakthrough Therapy designation for nipocalimab in treating moderate-to-severe Sjögre...

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