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GSK : FDA Approves Mepolizumab For Use In Adults With Chronic Rhinosinusitis With Nasal Polyps

GlaxoSmithKline plc (GSK,GSK.L) said that the US Food and Drug Administration has approved Nucala or mepolizumab, a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps or CRSwNP.

The new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Mepolizumab is the first anti-IL-5 biologic to be approved for adult patients with CRSwNP in the US. It is the Fourth indication for mepolizumab in the US for eosinophil-driven diseases.

Mepolizumab is also approved for use in three other eosinophilic driven diseases, the first indication being for patients with severe eosinophilic asthma aged six years and older. Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome.

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