FDA nod for first drug to treat HES in nearly 14 years

26 September 2020

On Friday, the US Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

The new indication for UK pharma major GlaxoSmithKline’s (LSE: GSK) Nucala is the first approval for HES patients in nearly 14 years, the FDA stated. GSK’s shares edged up 1.2% to 1,474.40 pence by close of trading yesterday.

First approved in 2015 for severe eosinophilic asthma, mepolizumab became the first-in-class monoclonal antibody that targets interleukin (IL)-5. Nucala is currently used as an add-on maintenance therapy for severe eosinophilic asthma and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), and is being investigated in several other eosinophil-driven diseases.

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