J&J files for FDA approval of IMAAVY in warm autoimmune hemolytic anemia based on Phase 2/3 ENERGY study

Johnson & Johnson submitted a supplemental Biologics License Application to the FDA for IMAAVY (nipocalimab-aahu) in warm autoimmune hemolytic anemia. The filing is based on the randomized, placebo-controlled Phase 2/3 ENERGY study. The company said full results are still to come, so the size of the benefit is not yet public.

• Supplemental BLA submitted for warm autoimmune hemolytic anemia (wAIHA)
• Basis: randomized, double-blind, placebo-controlled Phase 2/3 ENERGY study
• Full ENERGY results were still forthcoming at announcement