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# J&J Kills Nipocalimab Plus Tumor Necrosis Factor in RA
- URL: https://www.fdaweb.com/j-j-kills-nipocalimab-plus-tumor-necrosis-factor-in-ra/
- Published: 2025-08-29T12:00:00.000Z
- Updated: 2026-09-14T15:20:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159783

Johnson & Johnson has halted development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis (RA) after a mid-stage proof-of-concept study failed to show added benefit. The Phase 2a DAISY trial tested nipocalimab, an anti-FcRn antibody, alongside a tumor necrosis factor inhibitor in patients with refractory RA — those who had not responded adequately to existing therapies. After 12 weeks, the combination did not demonstrate meaningful improvements compared with anti-TNFα therapy alone, the company says, adding that no new safety signals were reported.

J&J characterized the study as an innovative attempt to expand nipocalimab’s reach into difficult-to-treat RA, but said it will not pursue the combo further. However, the drug remains a key part of J&J’s immunology pipeline, and it is being studied broadly in autoimmune and maternal-fetal medicine, including trials in systemic lupus erythematosus, myasthenia gravis, hemolytic disease of the fetus and newborn, and other antibody-driven conditions. Analysts have projected multi-billion-dollar potential for the therapy, which J&J has previously estimated could exceed $5 billion in peak annual sales.

Earlier this year, FDA [approved](https://www.fdaweb.com/fda-oks-j-js-imaavy-for-myasthenia-gravis/) a J&J BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis. The company described the therapy at the time as an immunoselective therapy designed to “substantially reduce immunoglobulin G (IgG), including harmful IgG autoantibodies, without additional detectable effects on other adaptive and innate immune functions.”