GSK’s Nucala Approved for Hypereosinophilic Syndrome

The FDA has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) to treat adults and children aged 12 years and older with hypereosinophilic syndrome (HES), a group of rare disorders linked to high levels of white blood cells.

The approval was based on the results of a phase 3 clinical trial in which only 28 percent of patients treated with Nucala had HES flare-ups compared to 56 percent of those given a placebo. In addition, patients treated with the monoclonal antibody experienced their first flare-up later than the placebo group.   

Nucala is the first drug approved in 14 years to treat HES, which leads to organ damage over time and may be fatal if left untreated.