FDA Approves Imaavy for wAIHA – Thalassaemia International Federation
Thalassaemia International Federation shared a post on LinkedIn:
”For the first time, people living with warm autoimmune haemolytic anaemia (wAIHA) have a treatment specifically approved for their disease by the U.S. Food and Drug Administration (FDA).
Imaavy (nipocalimab-aahu) has been approved for patients aged 12 years and older who are currently receiving or have previously received corticosteroids.
wAIHA is a rare and potentially life-threatening condition in which harmful antibodies attack and destroy the body’s red blood cells.
Until now, patients have depended largely on corticosteroids and other broad immunosuppressive therapies, often while facing relapses, debilitating fatigue, and serious complications.
In the pivotal ENERGY study, approximately three times as many participants receiving the approved dose achieved a durable haemoglobin response as those receiving placebo — 23.7 percent versus 7.7 percent.
Haemoglobin levels improved as early as the first week, alongside encouraging findings regarding fatigue and corticosteroid reduction.
TIF and the Rare Anaemias International Network (RAIN) warmly welcome this important development for the rare anaemias community.”
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