Shots:
- The US FDA has received an sBLA of 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 achieved stringent 1EP of a durable hemoglobin response & showed rapid as well as sustained improvement in fatigue as assessed by FACIT-Fatigue; full results to be presented in future
Ref: J&J | Image: J&J | Press Release
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