J&J Discontinues RA Combination Trial
Johnson & Johnson announced that it will not continue development of its drug Imaavy (nipocalimab) in combination with an anti-TNFα therapy for rheumatoid arthritis (RA), after a mid-stage study showed no added clinical benefit.
The decision was based on findings from the phase 2a Daisy proof-of-concept trial. In this study, patients with difficult-to-treat RA were evaluated after receiving the combination therapy for 12 weeks. The company reported that Imaavy did not provide additional improvement when layered on top of existing anti-TNFα treatment.
“Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA,” the company said in its release.
Future Potential Remains Strong
Although this represents a setback for Imaavy’s development in RA, Johnson & Johnson emphasized that the program continues to hold broad potential across other autoimmune and immune-mediated conditions. The company reiterated its estimate of more than $5 billion in peak sales potential for the therapy, describing itself as “confident” in the drug’s future prospects.
The investigational monoclonal antibody works by blocking the neonatal Fc receptor (FcRn), which is responsible for regulating levels of circulating immunoglobulin G (IgG) antibodies in the body. These antibodies are known contributors to the progression of multiple autoimmune disorders. Clinical findings have shown that Imaavy is capable of significantly lowering IgG levels, including disease-causing autoantibodies, while sparing other key functions of the immune system.
Competitive Landscape and Other Approvals
Imaavy has already received approval from the U.S. Food and Drug Administration to treat generalized myasthenia gravis (gMG), an authorization granted four months ago. The approval positioned Johnson & Johnson within a competitive market of FcRn-targeting therapies.
Argenx was the first to gain FDA approval in the space with its drug Vyvgart in 2021, followed by UCB’s Rystiggo in 2023. Johnson & Johnson has highlighted that Imaavy carries the broadest label for gMG among these drugs, which the company views as an advantage in reaching more patients.
Expanding Research and Development
Beyond gMG and RA, Johnson & Johnson has been expanding its evaluation of Imaavy into other autoimmune conditions. Last year, the company presented data from a phase 2 study in Sjogren’s disease (SjD).
The study marked the first time that the clinical benefit of an FcRn blocker had been demonstrated in this condition. The results helped secure a fourth FDA fast-track designation for Imaavy, adding to previous designations in gMG and two maternal-fetal disorders.
Johnson & Johnson originally added Imaavy to its pipeline through the $6.5 billion acquisition of Momenta Pharmaceuticals in 2020. The therapy was considered the centerpiece of that deal, underscoring its importance to the company’s long-term immunology strategy. While the discontinuation of the RA combination program narrows one area of development, the drug remains central to Johnson & Johnson’s ongoing research in immunology.
