Johnson & Johnson’s Imaavy granted Priority Review by FDA in hemolytic anemia

Johnson & Johnson announced that the FDA has granted Priority Review to the supplemental Biologics License Application, or sBLA, for Imaavy – nipocalimab-aahu -, confirming the urgent need for treatment options in warm autoimmune hemolytic anemia, or 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. Imaavy is the first therapy to receive FDA Priority Review for this condition. 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, a critical outcome for people living with wAIHA. Nipocalimab is being studied across multiple auto- and alloantibody-driven diseases as part of Johnson & Johnson’s broader commitment to advancing transformational immunology therapies.