J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results

Johnson & Johnson discontinued development of Imaavy (nipocalimab) for rheumatoid arthritis after its Phase 2a DAISY study failed to show a significant benefit when combined with anti-TNFα therapy compared to anti-TNFα therapy alone1 3 4 5.

The trial enrolled patients with moderate to severe, refractory rheumatoid arthritis and found no new safety concerns, but efficacy thresholds were not met1 3 4.

Imaavy, an FcRn-blocking antibody already approved for generalized myasthenia gravis (gMG), is still being developed for other rare and autoimmune IgG-mediated diseases, such as hemolytic disease of the fetus and newborn (HDFN) and Sjögren’s disease1 2 3 4.

J&J is shifting strategic focus to indications where Imaavy shows greater promise and less competition, capitalizing on its differentiated, pH-independent FcRn-blocking mechanism and advancing parallel development of other agents like JNJ-21131.

The decision follows J&J’s 2020 acquisition of Momenta Pharmaceuticals for $6.5 billion to gain access to nipocalimab, and the company remains confident in the drug's future blockbuster potential in other indications with over $5 billion potential value4.