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Treats generalized myasthenia gravis (gMG). Sold as Imaavy. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Nipocalimab-Aahu (sold as Imaavy), first approved Apr 29, 2025, with 1 new use approved and 0 published complete response letters.
First approved: Apr 29, 2025
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $20.5M
Orphan exclusivity until: Apr 29, 2032
First approved in the EU: Nov 28, 2025
First approved in Japan: Sep 19, 2025
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 5 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Imaavy, new ingredientDrugs with a new active ingredient indicated for the treatment of generalized myasthenia gravis (for use only in patients who have not sufficiently… · Janssen Pharmaceutical K.K. · Sep 19, 2025
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
