Johnson & Johnson has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for its drug Imaavy (nipocalimab) for the treatment of warm autoimmune hemolytic anemia (wAIHA).
The rare and serious autoimmune condition, which affects approximately one in 8,000 people, currently has no FDA-approved treatments. In wAIHA, pathogenic immunoglobulin G (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia.
The filing is based on data from a Phase II/III clinical trial in adults, which met its primary endpoint of a durable hemoglobin response compared to placebo. A durable response was defined as achieving a target hemoglobin level of 10 g/dL or higher, with an increase of at least 2 g/dL from baseline. This response had to be maintained for a minimum of 28 days without the need for additional therapy.
In addition to a rapid and sustained increase in hemoglobin levels, a greater proportion of patients treated with Imaavy showed improvement in fatigue, as measured by the FACIT-Fatigue scale, a factor the company noted is “important for those living with autoimmune hemolytic anemia.”
Johnson & Johnson acquired the rights to nipocalimab through its approximately $6.5 billion acquisition of Momenta Pharmaceuticals in 2020. In May, Imaavy was approved in the U.S. for the treatment of generalized myasthenia gravis (gMG) in adults and children aged 12 years and older.