IMAAVY has become the first FDA‑approved therapy for warm autoimmune haemolytic anaemia, offering a targeted approach designed to reduce pathogenic immunoglobulin G autoantibodies while preserving B‑cell function. The decision follows pivotal phase 2/3 data showing durable haemoglobin response.
In the study, patients treated with IMAAVY recorded a mean haemoglobin increase of 1 g/DL at Week 1. Investigators also reported improvement in FACIT‑Fatigue score at Week 24.
Warm autoimmune haemolytic anaemia affects around 1 in 8,000 people. Pathogenic IgG autoantibodies attach to and destroy red blood cells, leading to severe anaemia, profound fatigue and a significantly increased risk of morbidity and mortality.
People living with the condition continue to face a major unmet need for effective, well‑tolerated therapies that target disease‑driving IgG autoantibodies. Existing options have largely been limited to corticosteroids and immunosuppressants, which suppress the entire immune system rather than the specific autoantibodies responsible for the disease.
IMAAVY is designed to selectively target and reduce circulating IgG, including autoantibodies, while preserving B‑cell function. By lowering IgG levels, the therapy aims to address a key driver of warm autoimmune haemolytic anaemia and support durable disease control.
The company said the approval marks an important advance for patients who have long required more precise treatment options. Teresa Barata, PhD, Chief Scientific Officer, explained: “Harnessing the potent anti-tumor activity of IL-12 while limiting systemic toxicity has challenged researchers for almost 30 years.”
She added: “We are proud of the role our teams played in engineering this complex antibody format, developing a switch molecule that unmasks IL-12 only where it is needed.”
