FDA grants priority review of Nucala for patients with hypereosinophilic syndrome

GSK

27 May 2020 - An approval would give Nucala a third indication in an eosinophil driven disease.

GlaxoSmithKline today announced that the US FDA has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) in the treatment of patients with hypereosinophilic syndrome (HES) in the US.

If approval is obtained, it would make Nucala the first targeted biologic treatment for patients with this rare and life-threatening disease caused by eosinophilic inflammation. Treatment options are currently limited for patients with HES.

Read GSK press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier