Shots:
- The US FDA has accepted sBLA & granted priority review to J&J‘s Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA)
- sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period
- Trial showed that pts treated with Imaavy had a durable hemoglobin response, along with improvements in fatigue; full results to be presented in future
Ref: PRnewswire | Image: J&J | Press Release
Related News: Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026
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