J&J reports positive Phase 2/3 results for Imaavy in rare autoimmune anemia, paving way for label expansion

Johnson & Johnson announced that its drug Imaavy, already approved for myasthenia gravis, produced durable hemoglobin improvements in a Phase 2/3 trial for warm autoimmune hemolytic anemia, a rare condition that currently lacks approved treatments.

The study enrolled 115 adults who received two dosing levels of Imaavy or a placebo. After 24 weeks, participants receiving the drug maintained higher hemoglobin levels than those on placebo. The findings will be presented at the European Hematology Association meeting.

J&J said the data support a label expansion for Imaavy into this indication and noted a $300 million investment to back the launch for the rare‑disease market.