Johnson & Johnson Seeks FDA Approval of Imaavy as the First-Ever FDA-Approved Treatment for Warm Autoimmune Hemolytic Anemia
February 25, 2026
February 25, 2026
RARITAN, New Jersey, Feb. 25 -- Johnson and Johnson Innovative Medicine issued the following news release on Feb. 24, 2026:
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Johnson & Johnson seeks FDA approval of IMAAVY(R) (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
Data from the pivotal ENERGY trial showed IMAAVY(R) produced a rapid and durable hemoglobin responsea in wAIHA
Currently no FDA-approved therapies are availabl . . .
* * *
Johnson & Johnson seeks FDA approval of IMAAVY(R) (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
Data from the pivotal ENERGY trial showed IMAAVY(R) produced a rapid and durable hemoglobin responsea in wAIHA
Currently no FDA-approved therapies are availabl . . .