J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)
Shots:
- The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J‘s Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment
- In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb at Wk. 1 vs no change, with ~66.6% pts achieving both Hgb ≥10g/dL & a ≥2g/dL increase by Wk. 24. Imaavy also improved fatigue as early as Wk. 2 & sustained through 24wks., along with decrease in steroid use
- Results will be presented at EHA’26 and also support the sBLA for Imaavy in wAIHA, which was granted a US FDA priority review
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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