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Immunology
Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class
First-and-only FcRn blocker to demonstrate superiority in activities of daily living (MG-ADL
a
) over placebo when added to standard of care over 24 weeks in antibody positive patients: anti-AChR+, anti-MuSK+, anti-LRP4+
June 28, 2024
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Immunology
Johnson & Johnson spotlights nipocalimab at FMF Congress 2024 – the first and only FcRn blocker to be studied in maternal fetal diseases
The Phase 3 AZALEA and Phase 3 FREESIA clinical studies are enrolling pregnant individuals who are at risk for severe HDFN and FNAIT
These rare and potentially life-threatening alloantibody diseases affecting pregnant individuals and their fetus or newborn currently have no approved treatments
June 24, 2024
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Immunology
Late-breaking results show nipocalimab significantly improves Sjögren’s disease activity in a Phase 2 study
Patients who received nipocalimab 15 mg/kg demonstrated a greater than 70 percent relative average improvement on the primary endpoint compared to patients who received placebo
Sjögren’s disease is a chronic, debilitating, and prevalent autoantibody disease with no approved advanced treatments
June 15, 2024
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Immunology
Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology’s 2024 Annual Meeting
April 11, 2024
United States
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Immunology
Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults
March 26, 2024
United States
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Immunology
Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)
February 21, 2024
United States
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