Johnson & Johnson has reported results from the pivotal phase 2/3 Energy study evaluating Imaavy in patients with warm autoimmune hemolytic anemia (wAIHA), a life-threatening rare disease for which there are currently no approved therapies.
Imaavy became the third FcRn blocker approved since 2021 for generalized myasthenia gravis (gMG) when it received approval last year. The company is also studying the monoclonal antibody in several additional diseases, including wAIHA, where the latest trial results could support an expansion of its approved uses.
The Energy study enrolled 115 participants who were randomly assigned in a 1:1:1 ratio to receive one of two doses of Imaavy or a placebo. According to Johnson & Johnson, the study met its primary endpoint, demonstrating a statistically significant and durable red blood cell count response among treated patients.
Results showed that patients receiving the 30 mg/kg dose of Imaavy were three times more likely to achieve durable hemoglobin responses after 24 weeks compared with those receiving placebo. The primary endpoint was defined as an increase in hemoglobin of at least 2 g/dL from baseline and a hemoglobin concentration of at least 10 g/dL for a minimum of 28 days, without the need for rescue therapy or changes to background treatment. Johnson & Johnson said that nearly two-thirds of treated patients met both criteria by Week 24.
“Achieving hemoglobin improvements this quickly and at this scale is important in clinical practice, as it could help improve the debilitating fatigue that people living with warm autoimmune hemolytic anemia experience,” said Bruno Fattizzo, M.D., of the Department of Oncology and Hematology-Oncology at the University of Milan, Italy.
The company also reported that improvements in patient-reported fatigue were observed as early as Week 2 and were maintained throughout the treatment period, meeting a key secondary endpoint. Another secondary endpoint, reduction in steroid use, was also achieved. Johnson & Johnson stated that the safety profile observed in the study was consistent with previous experience using Imaavy in generalized myasthenia gravis.
Johnson & Johnson has already submitted an application seeking approval of the 30 mg/kg dose of Imaavy for wAIHA. The submission received FDA priority review designation in April, making it the first filing in the indication.
Leonard Dragone, M.D., Ph.D., Johnson & Johnson’s Disease Area Leader for Autotibody and Rheumatology, said the treatment’s effectiveness is linked to its immunoselective mechanism, which targets disease-causing autoantibodies while preserving key immune functions. He said this is important for people living with the disease who frequently suffer from comorbid conditions.
The company obtained Imaavy through its $6.5 billion acquisition of Momenta Pharmaceuticals in 2020. Beyond wAIHA and gMG, Johnson & Johnson is evaluating the therapy in several autoimmune and immune-mediated disorders. Phase 3 programs are underway in Sjogren’s disease, hemolytic disease of the fetus and newborn, fetal neonatal alloimmune thrombocytopenia, and chronic inflammatory demyelinating polyneuropathy. The drug is also being studied in phase 2 trials for systemic lupus erythematosus and idiopathic inflammatory myopathy.
Johnson & Johnson discontinued development of Imaavy as a combination treatment for rheumatoid arthritis after the drug did not meet expectations in a phase 2a study.
In the FcRn blocker market for generalized myasthenia gravis, Imaavy followed earlier approvals of Vyvgart from argenx in 2021 and Rystiggo from UCB in 2023. Argenx reported 2025 sales of $4.2 billion for Vyvgart, while UCB reported 2025 sales of 332 million euros ($375 million) for Rystiggo. Johnson & Johnson launched Imaavy in April last year and has not yet disclosed sales figures for the treatment.
Imaavy has demonstrated positive Phase 2/3 clinical trial results in patients with warm autoimmune hemolytic anemia (wAIHA), marking an important milestone in the development of new therapies for this rare autoimmune blood disorder. The encouraging findings highlight the potential of Imaavy to improve patient outcomes and support future regulatory discussions.
H2: Imaavy Meets Key Phase 2/3 Study Objectives
The latest clinical study showed that Imaavy achieved its primary efficacy goals while maintaining a safety profile consistent with previous research. The positive data suggest that Imaavy may help reduce the destruction of red blood cells, a defining characteristic of warm autoimmune hemolytic anemia, and improve overall disease management.
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