Who Can Get Imaavy, the First FDA-Approved Treatment for Warm Autoimmune Hemolytic Anemia

When the immune system turns on red blood cells, it usually shows up as tiredness, weakness and shortness of breath, and sometimes as yellow skin or eyes and dark urine (NORD). In warm autoimmune hemolytic anemia (wAIHA), the most common form, antibodies stick to red blood cells at normal body temperature and the spleen destroys the tagged cells faster than the body can replace them; in the rarer cold form, cold agglutinin disease, the antibodies grab red cells in the cold. When international experts wrote the first international consensus guidance on autoimmune hemolytic anemia in 2020, they summed up the treatment problem in 1 line: "There is currently no licensed treatment for AIHA" (Jäger et al., 2020).

On August 24th the FDA approved Imaavy (nipocalimab) for wAIHA, and the agency calls it the first FDA-approved treatment for the disease. If you or someone you care for has wAIHA and steroids have not been enough, this guide explains in plain terms who can get Imaavy, how the infusions work, what counted as success in its trial, what side effects showed up and how to pay for it.

Who Qualifies for Imaavy in Warm Autoimmune Hemolytic Anemia

Imaavy is approved for wAIHA in people 12 and older who are currently taking or have previously taken corticosteroids, according to its FDA label. The label's indication sets no minimum hemoglobin and no number of earlier treatments, though insurance plans can add their own rules before they pay, so ask your hematologist's office to check your plan.

The trial behind the approval was narrower. It enrolled people who had had wAIHA for at least 3 months, had been treated for it, had a hemoglobin below 10 g/dL with signs of active red cell destruction, and tested positive on a direct antiglobulin test (FDA). Their median age was 59, with a range of 24 to 86, and 92% of the people on the approved dose had primary wAIHA, meaning no other disease was causing it (Imaavy label).

The same medicine, made by Johnson & Johnson, was approved in 2025 for generalized myasthenia gravis. Imaavy blocks FcRn, a receptor that normally recycles IgG antibodies so they stay in the blood longer. With that recycling blocked, the body clears IgG faster, including the antibodies that tag red blood cells for destruction in wAIHA.

In the 24-week trial, 9 of 38 people on Imaavy (24%) had a durable hemoglobin response, compared with 3 of 39 on placebo (8%), according to the FDA label. Hemoglobin is the protein in red blood cells that carries oxygen, and in wAIHA it falls as red cells are destroyed, so a rise that lasts is the clearest sign a treatment is working.

The bar was high. A durable response meant a hemoglobin of at least 10 g/dL and at least 2 g/dL above where the person started, held for 3 visits in a row over at least 28 days without rescue treatment. People on Imaavy started at a median hemoglobin of 9.3 g/dL, so for the typical patient the 2 g/dL rule was the harder one, and counting as a responder meant climbing to about 11.3 g/dL and staying there. That figure is Trial Friend's arithmetic from the label's baseline table and its response definition, checked October 20, 2026.

The gap between the groups was 16 percentage points. By Trial Friend's arithmetic from that point estimate, that is roughly 1 extra responder for every 6 people treated. With only 77 people in the comparison, though, the true difference could be close to zero or about twice as large; the label's 95% confidence interval runs from 0.1 to 31.9 points.

A lower dose, 15 mg/kg every 2 weeks, did not lead to more responses than placebo (FDA), and the label recommends only the 30 mg/kg every-4-weeks schedule for wAIHA. Fatigue, scored on the 0 to 52 FACIT-Fatigue scale where higher means less tired, improved by about 3.5 points more on Imaavy than on placebo by week 24, though the label reports this without presenting it as a tested result.

Imaavy was tested on top of existing care. Patients were allowed to stay on stable doses of their wAIHA medicines. In the Imaavy group, 89.5% were taking corticosteroids when the trial began and 42% had received rituximab before it (Imaavy label).

How Imaavy Is Given for wAIHA

Imaavy for wAIHA is an IV infusion of 30 mg/kg, repeated every 4 weeks, according to the label. The first infusion runs over at least 30 minutes and later ones over at least 15 minutes. Myasthenia gravis uses a different schedule, a first dose of 30 mg/kg and then 15 mg/kg every 2 weeks, so people who read about Imaavy for MG should not expect the same visits.

Because Imaavy lowers IgG for a time, the label says to review age-appropriate vaccines before starting and does not recommend live vaccines during treatment.

Imaavy Side Effects in Warm Autoimmune Hemolytic Anemia

The most common side effects in the wAIHA trial were swelling in the legs or feet (12% on Imaavy vs 2.6% on placebo), diarrhea (12% vs 8%) and fever (10% vs 2.6%), according to the label. Other findings from the label are below. The infection, allergy and infusion figures come from the trial and its extension, in which 113 people received Imaavy.

• Infections: upper respiratory infections were reported in 34% and urinary tract infections in 12%, and the label's warnings section reports serious infections in 12%. Of the 113, 3 people (2.7%) stopped Imaavy because of an infection: pneumonia, a salmonella bloodstream infection and an abdominal infection called spontaneous bacterial peritonitis.
• Allergic reactions: 9 people (8%) had a hypersensitivity reaction. The label says Imaavy should not be used by anyone who has had a serious one to it, including anaphylaxis or angioedema.
• Infusion reactions: 12 people (11%) had one, and 1 person stopped because of an infusion-related reaction (back pain).
• Cholesterol: fasting total cholesterol rose by a mean of 6 mg/dL at week 24 in the trial's double-blind phase.
• Pregnancy: human data are limited, and monkey studies showed placental damage with fetal loss. Imaavy also lowers the antibodies a mother passes to her baby, so the label says a newborn's protection against infection may be reduced for 6 months or more.

Warm Autoimmune Hemolytic Anemia Treatment Options, and Where Imaavy Fits

Imaavy joins the existing options rather than replacing the first one. The 2020 international consensus names corticosteroids as first-line treatment for wAIHA and says adding rituximab should be considered early in severe cases or when steroids do not work quickly (Jäger et al., 2020).

wAIHA is linked to a higher risk of blood clots, mostly in the weeks after diagnosis and more often with severe hemolysis or after spleen removal, according to NORD. Ask whether you need anything to lower that risk, whichever treatment you start.

Paying for Imaavy, From $0 Copays to Free Medicine for a Year

Johnson & Johnson's IMAAVY withMe Savings Program says eligible patients with commercial or private insurance may pay as little as $0 per infusion, with separate help for the medicine itself and for some infusion and monitoring costs. A yearly maximum applies and monthly maximums may apply, and the program is not valid for people using Medicare, Medicaid or other government programs to pay (J&J withMe, checked October 20, 2026).

People who are uninsured, or whose coverage does not fully meet their needs, including some with government coverage, may get Imaavy free for up to 1 year through the Johnson & Johnson Patient Assistance Program if they meet its eligibility and income rules. Both programs use the phone number 844-494-8463. Trial Friend keeps the current program details for Imaavy on its help-paying page, and its guide to what happens between an FDA approval and a first dose covers the steps that come before a newly approved drug reaches a patient.

HealthWell Foundation's fund list had no wAIHA fund when Trial Friend checked it on October 20, 2026, and J&J's page refers patients to The Assistance Fund, Accessia Health and NORD, each with its own rules.

wAIHA Clinical Trials Open Now, Including LUMINA 3 for a Rilzabrutinib Pill

Trial Friend counts 11 wAIHA studies on ClinicalTrials.gov that are recruiting (7) or not yet recruiting (4), including 1 observational study, and 4 of the 11 list a US site (Trial Friend's count of ClinicalTrials.gov records, checked October 20, 2026). The full list, with plain-language entry rules, is on the wAIHA trials page, and wAIHA trials near you sorts the open ones by distance.

LUMINA 3 and rilzabrutinib

Sanofi is testing rilzabrutinib, a pill that blocks an enzyme called BTK and is already approved for immune thrombocytopenia, against placebo in LUMINA 3 (NCT07086976). The trial plans to enroll about 90 adults at 105 sites, 27 of them in the US, and lists May 2028 as its estimated primary completion date.

Its entry rules are specific. Adults need primary wAIHA for at least 6 months, plus steroids that did not work within 3 weeks at 1 mg/kg or 60 mg of prednisone a day, needed more than 10 mg a day to keep a response, or could not be taken. Anyone whose wAIHA comes from another condition, such as lupus or a lymphoma, who has Evans syndrome, or who has already taken a BTK inhibitor for wAIHA is excluded.

Ianalumab, obexelimab and cell therapies

Phase 3 trials of ianalumab from Novartis (NCT05648968) and of obexelimab from Zenas BioPharma (NCT05786573) have finished enrolling and are still running. Earlier-stage studies are testing cell therapies in people whose wAIHA came back or did not respond, including CRISPR Therapeutics' CTX112 (NCT07549698), which has 3 US sites, in Boston; Rochester, Minnesota; and Omaha.

Imaavy and wAIHA in Plain Answers

The 2020 consensus abstract ends by calling for future recommendations to be based on prospective clinical trials whenever possible. Imaavy's placebo-controlled trial is that kind of evidence, and 3 more Phase 3 trials, LUMINA 3 and the ianalumab and obexelimab studies, are under way.