NovImmune SA

FDA Approves First Treatment for Primary Hemophagocytic Lymphohistiocytosis, Marking 24-Year Breakthrough

- The FDA has approved emapalumab-lzsg (Gamifant) as the first treatment specifically indicated for primary hemophagocytic lymphohistiocytosis (HLH), an ultra-rare and life-threatening immune disorder. - In a pivotal phase 2/3 study of 27 patients with refractory disease, 63% demonstrated overall response and 70% proceeded to hematopoietic stem cell transplant. - The monoclonal antibody targets interferon gamma, representing the first significant improvement in primary HLH induction therapy in 24 years. - Primary HLH typically affects children within the first year of life and has a median survival of less than two months without treatment.