US EditionFDA Approves Nipocalimab for Adult and Pediatric Myasthenia Gravis
- On May 1, 2025, Johnson & Johnson obtained FDA approval for nipocalimab to treat generalized myasthenia gravis in patients 12 years and older, including both adults and adolescents, in the United States.
- This approval follows J&J's 2020 acquisition of Momenta Pharmaceuticals for $6.5 billion, gaining nipocalimab, an FcRn blocker developed to target the broadest gMG patient population positive for anti-AChR and anti-MuSK antibodies.
- Nipocalimab demonstrated sustained symptom relief and durable disease control over 24 weeks in pivotal studies including Vivacity-MG3 and Vibrance-MG, showing reductions in autoantibody levels up to 75% and 69% in adults and children respectively.
- Johnson & Johnson has priced Imaavy at $12,480 for each vial, aiming to offer a competitive option within the FcRn blocker class alongside Argenx’s Vyvgart and UCB’s Rystiggo. The company anticipates that this therapy could eventually generate annual sales of up to $5 billion across a range of indications.
- Approval of nipocalimab broadens treatment options for a disease affecting about 700,000 people worldwide, including underserved pediatric patients, and suggests potential expansion into other autoantibody-driven diseases now under J&J’s development.
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12 Articles
FDA Nod for J&J Autoimmune Drug is First of Potentially Many for the Projected Blockbuster Product
Johnson & Johnson’s Imaavy is now FDA-approved for treating generalized myasthenia gravis, introducing competition to Argenx and UCB drugs that treat this rare neuromuscular disorder. J&J is also developing its new drug for other diseases and projects it could reach $5 billion in peak sales across multiple rare and prevalent conditions. The post FDA Nod for J&J Autoimmune Drug is First of Potentially Many for the Projected Blockbuster Product ap…
FDA Approves Nipocalimab for Adult and Pediatric Myasthenia Gravis
(MedPage Today) -- The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody...
FDA Approves Johnson & Johnson’s IMAAVY for Generalized Myasthenia Gravis
SPRING HOUSE, PA — On Wednesday, the U.S. Food and Drug Administration (FDA) granted approval for IMAAVY™ (nipocalimab-aahu), Johnson & Johnson’s cutting-edge FcRn-blocking antibody treatment for generalized myasthenia gravis (gMG). This approval makes IMAAVY the first and only FcRn blocker available for adults and pediatric patients aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody posit…
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