Imaavy FDA Approval History
Last updated by Judith Stewart, BPharm on May 4, 2025.
FDA Approved: Yes (First approved April 29, 2025)
Brand name: Imaavy
Generic name: nipocalimab-aahu
Dosage form: Injection
Company: Johnson & Johnson Innovative Medicine
Treatment for: Myasthenia Gravis
Imaavy (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) blocker used for the treatment of generalized myasthenia gravis.
- Imaavy is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-musclespecific tyrosine kinase (MuSK) antibody positive.
- Generalized myasthenia gravis 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.
- Imaavy 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.
- FDA approval of Imaavy was supported by data from the pivotal, ongoing Vivacity-MG3 study which demonstrated:
- superior disease control with standard of care (SOC) throughout 24 weeks when compared to placebo plus SOC;
- 20 months of lasting disease control and symptom relief; and
- rapid and sustained reduction in autoantibody levels by up to 75% from the first dose and throughout a 24-week period of monitoring. - Imaavy is administered by intravenous infusion over at least 30 minutes for the initial dose, then every two weeks over at least 15 minutes for the maintenance doses.
- Warnings and precautions associated with Imaavy include infections, hypersensitivity reactions, and infusion-related reactions.
- Common adverse reactions (≥10%) include respiratory tract infections, peripheral edema, and muscle spasms.
- Nipocalimab is also being studied in:
- Warm Autoimmune Hemolytic Anemia (Phase 3 ENERGY)
- Sjogren's Disease (Phase 3)
- Hemolytic Disease of the Fetus and Newborn (Phase 3 AZALEA)
- Fetal and Neonatal Alloimmune Thrombocytopenia (Phase 3 FREESIA)
- Systemic Lupus Erythematosus (Phase 2)
- Idiopathic Inflammatory Myopathy (Phase 2)
- Chronic Inflammatory Demyelinating Polyneuropathy (Phase 3 ARISE)
- Generalized Myasthenia Gravis Pediatrics (Phase 2 VIBRANCE MG)
- Rheumatoid Arthritis combination therapy (Phase 2)
Development timeline for Imaavy
Further information
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