FDA Expands Imaavy Approval to Rare Autoimmune Blood Disorder

Johnson & Johnson has secured the first FDA label expansion for Imaavy, extending the treatment’s use to patients with warm autoimmune hemolytic anemia, also known as wAIHA.

The approval comes just 16 months after Imaavy first received FDA clearance for generalized myasthenia gravis. It covers adults and adolescents aged 12 and older with wAIHA who are currently using corticosteroids or have previously received them.

Warm autoimmune hemolytic anemia is a rare and potentially life-threatening condition in which immunoglobulin G autoantibodies mistakenly attack and destroy red blood cells. This can cause anemia, severe fatigue, weakness and other complications. Patients may experience recurring periods of improvement followed by sudden declines in hemoglobin levels, creating significant uncertainty around the course of the disease.

Imaavy is an immunoselective neonatal Fc receptor blocker designed to reduce the harmful IgG autoantibodies associated with the condition. With the expanded approval, it becomes the first FDA-approved treatment for wAIHA to directly target the autoantibodies believed to drive the disease.

The FDA’s decision was supported by results from a phase 2/3 clinical trial involving 115 participants. Patients were randomly assigned to receive one of two Imaavy doses or a placebo. After 24 weeks, three times as many patients receiving the 30 mg/kg dose achieved durable hemoglobin responses compared with those given a placebo, according to results reported by Fierce Pharma.

The approval represents an important development for patients whose disease remains uncontrolled despite corticosteroid treatment. It may also reduce reliance on broader immunosuppressive approaches by offering a therapy designed around a specific biological mechanism.

Johnson & Johnson acquired Imaavy through its $6.5 billion purchase of Momenta Pharmaceuticals in 2020. The company has identified the medicine as a potential blockbuster, estimating that it could eventually generate peak annual sales of at least $5 billion. However, it has not yet disclosed sales figures for the treatment.

The wAIHA approval may be the first of several expansions for Imaavy. The medicine is currently undergoing phase 3 testing in Sjögren’s disease, hemolytic disease of the fetus and newborn, and fetal and neonatal alloimmune thrombocytopenia. It is also being investigated in systemic lupus erythematosus and several other immune-mediated conditions.

These development programs could broaden Imaavy’s clinical role considerably, while reinforcing the growing importance of targeted FcRn therapies across autoimmune and antibody-driven diseases.

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