The first and only FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)1
The first and only FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)1
IMAAVY delivers a durable Hgb response* and an increase of 1 g/dL (mean) was observed at Week 1† in IMAAVY-treated patients1
*Durable Hgb response: IMAAVY 24% (9/38) vs placebo 8% (3/39) (one-sided P value=0.015) in a 24-week clinical trial. Durable Hgb response is defined as an Hgb level of ≥10 g/dL and an increase from baseline of ≥2 g/dL for at least 3 consecutive study visits ≥28 days, where criteria were met starting by Week 16 of the double-blind period without the need for rescue therapy.1
†Results are considered descriptive based on the study’s prespecified statistical analysis plan. Therefore, statistical significance has not been established.
See the data
For patients discontinuing treatment or receiving rescue therapy before Week 24, change from baseline was set to zero for all subsequent visits.
Targeted FcRn-blocker designed to reduce IgG1-5
- Designed to target and reduce pathogenic IgG autoantibodies while preserving B-cell function
- The median reduction in total IgG at Week 1 was ~70%, with reductions in total IgG observed at Week 1 and through Week 24
- Based on in vivo and/or in vitro studies. The clinical significance of these characteristics is not fully known
Durable Hgb response1
- Significantly more patients achieved a durable Hgb response (IMAAVY 24% [9/38] vs
placebo 8% [3/39]; one-sided
P value = 0.015)‡ - Durable Hgb response is defined as an Hgb level of ≥10 g/dL and an increase from baseline of ≥2 g/dL for at least 3 consecutive study visits ≥28 days, where criteria were met starting by Week 16 of the double-blind period without the need for rescue therapy
Additional Hgb response analysis1,6,7
- A mean increase in Hgb of 1 g/dL observed at Week 1 in IMAAVY-treated patients
- 61% (n=23/38) of patients on IMAAVY vs 15% (n=6/39) of patients on placebo had an increase in Hgb ≥2 g/dL at any visit AND Hgb ≥10 g/dL by
Week 24§ - Results are considered descriptive based on the study’s prespecified statistical analysis plan. Therefore, statistical significance has not been established.
Proven safety profile over 24 weeks1
- The most common AEs (≥10% of patients treated with IMAAVY) were peripheral edema, diarrhea, and pyrexia
- Patients on IMAAVY may experience serious AEs, such as infections, hypersensitivity reactions, and infusion-related reactions
AE=adverse event; FcRn=neonatal fragment crystallizable receptor; Hgb=hemoglobin; IgG=immunoglobulin G; MOA=mechanism of action.
‡The one-sided P values use an alpha level of 0.02499. Statistically significant based on equal weight multiple comparison testing procedure.
§At any visit refers to ≥1 visit.
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References: 1. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Seth NP, Xu R, DuPrie M, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025;17(1):1–22. doi:10.1080/19420862.2025.2461191 3. Cossu M, Bobadilla Mendez C, Jackson A, et al. A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants. Hum Vaccin Immunother. 2025;21(1):2491269. doi:10.1080/21645515.2025.2491269 4. Pyzik M, Sand KMK, Hubbard JJ, Andersen JT, Sandlie I, Blumberg RS. The neonatal Fc receptor (FcRn): a misnomer? Front Immunol. 2019;10:1540. doi:10.3389/fimmu.2019.01540 5. Fattizzo B, Murakhovskaya I, Ueda Y, et al. Pharmacodynamic effect of nipocalimab in warm autoimmune hemolytic anemia (WAIHA) and correlation with clinical improvement. Poster presented at: European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden. Poster PF1297. 6. Fattizzo B, Murakhovskaya I, Ueda Y, et al. Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized double-blind ENERGY study. Presented at: European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden. Abstract S300. 7. Data on file. Janssen Biotech, Inc.