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Nipocalimab Granted FDA Breakthrough Therapy Designation for Sjögren's Disease

• Johnson & Johnson's nipocalimab, an anti-FcRn antibody, has received FDA Breakthrough Therapy Designation for moderate-to-severe Sjögren's Disease (SjD). • The designation aims to expedite the development and review of nipocalimab, addressing a significant unmet need in SjD treatment. • Phase 2 DAHLIAS study results showed statistically significant improvement in ClinESSDAI scores in nipocalimab-treated patients versus placebo. • A phase 3 trial is underway, as there are currently no approved treatments addressing the underlying causes of SjD.

Johnson & Johnson (J&J) has announced that nipocalimab, its anti-FcRn antibody, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe Sjögren's disease (SjD). This marks nipocalimab as the first investigational therapy to receive this designation for SjD.
The FDA grants BTD to accelerate the development and regulatory review of potential new medicines intended for serious conditions where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies, addressing a significant unmet medical need.

Sjögren's Disease and the Need for New Therapies

SjD is a chronic autoimmune disease affecting an estimated four million people globally. It is characterized by symptoms such as mucosal dryness, joint pain, and fatigue. Extraglandular manifestations are also common, impacting multiple organ systems, including the joints, lungs, kidneys, and nervous system. Currently, there are no approved treatments that directly address the underlying causes of SjD, highlighting the critical need for innovative therapies to improve patient outcomes.

Nipocalimab: Targeting FcRn to Reduce IgG Antibodies

Nipocalimab is designed to block the neonatal Fc receptor (FcRn), which plays a key role in regulating the levels of circulating immunoglobulin G (IgG) antibodies. By blocking FcRn, nipocalimab aims to reduce IgG antibody levels, potentially without affecting other immune functions. This mechanism of action could provide a targeted approach to managing the autoimmune response in SjD.

Positive Phase 2 Results from the DAHLIAS Study

The FDA's decision to grant BTD was supported by positive results from the Phase 2 DAHLIAS study. This study evaluated the effects of nipocalimab in over 160 adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. Results presented at the European Alliance of Associations for Rheumatology Congress demonstrated a statistically significant and clinically meaningful improvement in the ClinESSDAI score in nipocalimab-treated SjD patients compared to placebo at 24 weeks compared to baseline. The ClinESSDAI score measures disease activity across 11 organ systems.

Ongoing Phase 3 Trial and Future Directions

J&J has initiated a Phase 3 trial to further evaluate the efficacy and safety of nipocalimab in SjD patients. According to Terence Rooney, vice president, rheumatology, immunology disease area leader, J&J Innovative Medicine, this announcement represents an important step forward in the development of nipocalimab, emphasizing its potential as the first FcRn blocker to demonstrate positive Phase 2 results in SjD patients. The ongoing Phase 3 trial will provide further insights into the potential of nipocalimab to address the unmet needs in SjD treatment.
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Reference News

[1]
J&J's nipocalimab granted FDA breakthrough designation for Sjögren's disease - PMLiVE
pmlive.com · Nov 13, 2024

J&J's nipocalimab granted breakthrough therapy designation by FDA for treating moderate-to-severe Sjögren’s disease, sup...

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