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
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

Further information

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