Novimmune, a Swiss biotech company focused on the discovery and development of antibody-based drugs, has submitted a Biologics License Application to the US Food and Drug Administration (FDA) seeking marketing approval for its lead compound, emapalumab (NI-0501), for the treatment of a life threatening disease in children.
Novimmune’s lead compound is a treatment for patients with Hemophagocytic Lymphohistiocytosis (HLH), a clinical syndrome of hyperinflammation, characterized by severe hyperferritinemia, fever, severe cytopenia, coagulation defects and organomegaly. Primary HLH typically arises in pediatric patients, is lethal if untreated, and has a 40% mortality rate with current best available care.
Novimmune Chairman and Chief Executive Officer Eduard Holdener said: “This is a very special moment in the history of our company as emapalumab is Novimmune’s first medicine to be submitted for regulatory approval.” Cristina de Min, Novimmune’s Chief Medical Officer, added, “The emapalumab research and development program has made significant progress in the understanding, diagnosis and management of this life threatening disease in children. We look forward to working with the FDA during the review process for the first targeted therapy for primary HLH.”
Novimmune is also preparing a Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA) later this year.
(Press release)
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