Nipocalimab FDA Approval Status
Last updated by Judith Stewart, BPharm on Sep 4, 2024.
FDA Approved: No
Generic name: nipocalimab
Company: Johnson & Johnson Innovative Medicine
Treatment for: Myasthenia Gravis
Nipocalimab is a neonatal Fc receptor (FcRn) blocker in development for the treatment of generalized myasthenia gravis.
- Generalized myasthenia gravis (gMG) is an autoantibody disease characterized by fluctuating weakness of the skeletal muscles leading to symptoms such as limb weakness, drooping eyelids, double vision and difficulties with chewing, swallowing, speech, and breathing. It is caused by autoantibodies targeting proteins at the neuromuscular junction to disrupt neuromuscular signaling, and impair or prevent muscle contraction.
- Nipocalimab works in the treatment of generalized myasthenia gravis by binding with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, which have an important role in the pathogenesis of many autoimmune diseases including myasthenia gravis.
- A Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of nipocalimab for the treatment of people living with gMG. The application included data from the Phase 3 Vivacity-MG3 program which demonstrated that outcomes for a broad population of antibody positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
- Nipocalimab is also being studied in:
- Hemolytic Disease of the Fetus and Newborn (Phase 3 AZALEA)
- Warm Autoimmune Hemolytic Anemia (Phase 3 ENERGY)
- Chronic Inflammatory Demyelinating Polyneuropathy (Phase 3 ARISE)
- Idiopathic Inflammatory Myopathy (Phase 2)
- Sjogren's Disease (Phase 2)
- Systemic Lupus Erythematosus (Phase 2)
- Rheumatoid Arthritis (Phase 2)
- Generalized Myasthenia Gravis Pediatrics (Phase 2 VIBRANCE MG)
Development timeline for nipocalimab
| Date | Article |
|---|
| Mar 18, 2025 | Nipocalimab, the First and Only Investigational Treatment to be Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Adults with Moderate-to-Severe Sjögren’s Disease, has now Received Fast Track Designation |
| Jan 23, 2025 | Findings From Pivotal Nipocalimab Phase 3 Study in a Broad Antibody Positive Population of People Living with Generalized Myasthenia Gravis (gMG) Published in The Lancet Neurology |
| Jan 9, 2025 | Nipocalimab Granted U.S. FDA Priority Review for the Treatment of Generalized Myasthenia Gravis |
| Nov 11, 2024 | Nipocalimab is the First and Only Investigational Therapy Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Adults Living with Moderate-to-Severe Sjögren’s Disease |
| Oct 15, 2024 | Nipocalimab Demonstrates Sustained Disease Control in Adolescents Living with Generalized Myasthenia Gravis in Phase 2/3 study |
| Aug 29, 2024 | Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia Gravis |
| Aug 7, 2024 | Groundbreaking Nipocalimab Study of Pregnant Individuals at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn Published in The New England Journal of Medicine |
| Jun 15, 2024 | Late-Breaking Results Show Nipocalimab Significantly Improves Sjögren’s Disease Activity in a Phase 2 Study |
| Mar 26, 2024 | 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 |
| Feb 9, 2024 | 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) |
| Feb 5, 2024 | Johnson & Johnson Reports Positive Topline Results for Nipocalimab From a Phase 3 Pivotal Study in Generalized Myasthenia Gravis (gMG) and a Phase 2 Study in Sjögren's Disease (SjD) |
| Nov 7, 2023 | Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study |
| Jun 26, 2023 | New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) |
| Feb 6, 2023 | Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) |
| Jul 28, 2020 | Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN |
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