Nipocalimab

Generic Name
Nipocalimab
Brand Names
-
Drug Type
Biotech
Chemical Formula
-
CAS Number
2211985-36-1
Unique Ingredient Identifier
87M90CV8NC
Background

Nipocalimab is under investigation in clinical trial NCT04119050 (Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia).

Associated Conditions
-
Associated Therapies
-
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FDA Grants Breakthrough Therapy Designation for Nipocalimab to Treat Sjögren Disease

The FDA granted breakthrough therapy designation to nipocalimab (Johnson & Johnson) for treating moderate-to-severe Sjögren disease (SjD), the first for this condition. SjD, a chronic autoantibody disease, primarily causes dry eyes and mouth, often coexisting with rheumatoid arthritis and lupus. Nipocalimab, an FcRn blocker, showed positive results in a phase 2 study, with improvements in disease activity and symptoms like dryness. A phase 3 study is ongoing, aiming to address the disease's underlying causes and improve patient outcomes.
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