Novimmune’s NI-0501 Secures Breakthrough Designation

Switzerland-based Novimmune has raked in breakthrough therapy designation for NI-0501 to treat patients with primary hemophagocytic lymphohistiocytosis with refractory disease, or with recurrent or progressive disease during traditional chemotherapy.

The anti-interferon-gamma monoclonal antibody would be the first targeted therapy for this disease.

The FDA’s decision was based on data from a Phase 2 clinical trial in children suffering from HLH.

The therapy garnered orphan drug status from the FDA and EMA in 2010.