SPRING HOUSE, Pa. — Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® (nipocalimab-aahu),c confirming the urgent need for treatment options in warm autoimmune hemolytic anemia (wAIHA). Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately six months.1 IMAAVY is the first therapy to receive FDA Priority Review for this condition.
“Warm autoimmune hemolytic anemia is a severe disease in which pathogenic immunoglobulin G (IgG) antibodies, also called autoantibodies, drive destruction of red blood cells. Currently, patients depend on broad immunosuppressive therapies that fail to address the underlying cause of disease and are not approved as safe or effective to treat wAIHA,” said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. “This designation highlights both the serious, life-threatening nature of wAIHA and the potential for IMAAVY, if approved, to help address a critical unmet need by delivering clinically meaningful outcomes for patients.”
IMAAVY is designed to block the neonatal Fc receptor (FcRn), reducing circulating IgG, including pathogenic autoantibodies, while preserving key immune functions.2,3 By targeting the underlying driver of disease, IMAAVY utilizes a differentiated immunoselective approach in a condition where many patients currently rely on therapies that are unapproved for wAIHA, including corticosteroids and broad immunosuppressants.4
The FDA’s decision to grant Priority Review is supported by results from the pivotal Phase 2/3 ENERGY study, which showed that more patients treated with IMAAVY achieved a durable hemoglobin responsea compared with placebo, along with improvements in fatigue,b a critical outcome for people living with wAIHA.5 The full results of the ENERGY trial will be presented at an upcoming medical conference.
Nipocalimab is being studied across multiple auto- and alloantibody-driven diseases as part of Johnson & Johnson’s broader commitment to advancing transformational immunology therapies.
Editor’s Notes:
a. Durable hemoglobin response = hemoglobin concentration ≥10 g/dL and an increase from baseline in hemoglobin ≥2 g/dL for at least 28 days
b. As measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
c. IMAAVY is not approved by the U.S. FDA for the treatment of wAIHA
ABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo, followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA).5
ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia. Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.4,6 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.7,8 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.9
There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of unapproved corticosteroids, broad immunosuppressants, and B-cell directed therapies.4 With an unmet need for treatment in wAIHA, novel therapies like nipocalimab are being developed to potentially address this need.8
ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.10
Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.11,12,13,14,15,16,17,18,19,20
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:
- EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025
- U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren’s disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026
- U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
- U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024
- U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026
The legal manufacturer for IMAAVY is Janssen Biotech, Inc.
WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
It is not known if IMAAVY is safe and effective in children under 12 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about IMAAVY?
IMAAVY is a prescription medicine that may cause serious side effects, including:
- Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:
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- Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:
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- Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion:
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Do not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY®. Reactions have included angioedema and anaphylaxis.
Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:
- ever had an allergic reaction to IMAAVY.
- have or had any recent infections or symptoms of infection.
- have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.
- are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.
Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See “What is the most important information I should know about IMAAVY?”
The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.
These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.
Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.
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References
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2 Ling LE., et al. M281, an anti‐fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first‐in‐human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
3 Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
4 Sudulagunta SR, et al. Warm Autoimmune Hemolytic Anemia: Clinical Profile and Management. J Hematol. 2017 Mar; 6(1): 12–20. Published online 2017 Mar 21. doi: 10.14740/jh303w.
5 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://www.clinicaltrials.gov/study/NCT04119050
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8 Cherif H, Ca Q, Crivera C, Leon A, Rahman I, Leval A, Noel W, Kjellander C. Overall survival and treatment patterns among patients with warm autoimmune hemolytic anemia in Sweden: A nationwide population-based study. 2024.
9 Fattizzo B, Barcellini W. New therapies for the treatment of warm autoimmune hemolytic anemia. Transfusion Medical Reviews. 2022;36(4). https://doi.org/10.1016/j.tmrv.2022.08.001
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