Treats generalized myasthenia gravis (gMG). BLA 761430, held by Janssen Biotech. Nipocalimab-Aahu.
As of Nov 13, 2026, BLA 761430 (Imaavy), held by Janssen Biotech, was first approved by FDA on Apr 29, 2025, with 1 approved supplement and 0 published complete response letters.
IMAAVY is a neonatal Fc receptor blocker 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-muscle-specific tyrosine kinase (MuSK) antibody positive. warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 24, 2026 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Apr 29, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Imaavy300MG/1.62ML(185MG/ML) · injectable;injection | Nipocalimab-Aahu | Rx |
| Imaavy1200MG/6.5ML(185MG/ML) · injectable;injection | Nipocalimab-Aahu | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
