Reported Earlier, FDA Approves Johnson & Johnson's IMAAVY...

Reported Earlier, FDA Approves Johnson & Johnson's IMAAVY (Nipocalimab-Aahu) As First-Ever Treatment For Warm Autoimmune Hemolytic Anemia, Based On Pivotal Phase 2/3 ENERGY Study

Benzinga Newsdesk www.benzinga.com Positive 90.4%

Neg 0% Neu 0% Pos 90.4%

IMAAVY is an immunoselective FcRn blocker designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell function
Warm autoimmune hemolytic anemia is a rare, life-threatening disease in which autoantibodies cause the destruction of red blood cells, leading to severe anemia and debilitating fatigue
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 1b and improvement in FACIT-Fatigue score at Week 24 were observed in IMAAVY-treated patients