FDA approves IMAAVY as first treatment for warm autoimmune hemolytic anemia

The FDA approved IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia in adults and in patients aged 12 and older who have received corticosteroids. It is the first therapy approved specifically for this disease, and it is IMAAVY's second U.S. indication after generalized myasthenia gravis. The approval rests on the Phase 2/3 ENERGY study of 115 adults, in which about three times as many patients on the approved dose reached a durable hemoglobin response as on placebo by week 24.

• Approved for warm autoimmune hemolytic anemia in adults and patients 12 and older
• ENERGY: 23.7% durable hemoglobin response on IMAAVY vs 7.7% on placebo at week 24
• Median time to first response 4.1 weeks on IMAAVY vs 12.1 weeks on placebo
• Most common adverse reactions: peripheral edema, diarrhea and fever