16 March 2016 - Novimmune today announced that the US FDA has granted breakthrough therapy designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy.

NI-0501 is a fully human, anti-interferon-gamma (IFNγ) monoclonal antibody discovered and developed by Novimmune. The biological activity of IFNγ, which is considered to have a pivotal pathogenic role in HLH, is neutralized by NI-0501, the first targeted therapy for this disease.

For more details, go to: http://www.novimmune.com/news/pr160316.html