FDA Approves IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia
The U.S. FDA approved IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
IMAAVY, an immunoselective neonatal fragment crystallizable receptor (FcRn) blocker, is the first FDA-approved treatment for wAIHA and is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell function. The approval is based on the pivotal Phase 2/3 study, which demonstrated durable hemoglobin response. A mean increase in hemoglobin of 1 g/DL at Week 1 and improvement in FACIT-Fatigue score at Week 24 were observed in IMAAVY-treated patients.i
Why this is important:
- In wAIHA, which impacts approximately 1 in 8,000 people, pathogenic IgG autoantibodies attach to and destroy red blood cells, causing severe anemia, profound fatigue, and a significantly increased risk of morbidity and mortality.ii
- People living with wAIHA continue to have a significant unmet need for effective, well-tolerated therapies that target disease-driving pathogenic IgG autoantibodies. Durable disease control is the ultimate goal in treating wAIHA. Previously, available treatment options only included corticosteroids and immunosuppressants – therapies that suppress the entire immune system without specifically targeting the IgG autoantibodies driving the disease.iii
- IMAAVY is an immunoselective therapy designed to target and reduce pathogenic immunoglobulin G (IgG). By reducing circulating IgG, including autoantibodies, IMAAVY targets a key driver of wAIHA while preserving B-cell function.iv,v
For more information contact:
Christine Murphy | Senior Vice President, Media
3 World Trade Center | 175 Greenwich Street | 31st Floor
New York, NY 10006
Total Page Views: 3
