On 24 August 2026, the FDA approved a supplemental application for Imaavy (nipocalimab-aahu). The FDA classified the supplement as an efficacy submission under biologics license application BLA 761430. Janssen Biotech was identified as the sponsor.
Background
Imaavy is the brand name associated with nipocalimab, also identified in the supplied record as nipocalimab-aahu. The event concerns a supplemental application reviewed by the FDA and classified under efficacy. The supplied data do not describe the drug’s mechanism, therapeutic indication, dosing, or any prior approval history.
What this means
The FDA action records approval of a supplemental efficacy application for Imaavy. This establishes that the supplement was approved in the FDA’s biologics application database, but the supplied event information does not specify the clinical use, patient population, efficacy endpoint, treatment effect, or label language associated with the supplement.
No clinical trial identifier, outcome measurements, comparative results, p-values, confidence intervals, or safety findings were provided. The event therefore supports reporting the regulatory action itself, but not a numerical assessment of efficacy or conclusions about how the supplement changes use of Imaavy.
Source
Source: FDA, biologics license application database overview entry for BLA 761430, supplemental application BLA761430-SUPPL-2, dated 24 August 2026. The source is available at accessdata.fda.gov.