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GlaxoSmithKline wins FDA approval for Nucala for treating patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

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M2 EQUITYBITES-July 30, 2021-GlaxoSmithKline wins FDA approval for Nucala for treating patients with chronic rhinosinusitis with nasal polyps (CRSwNP)

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Healthcare company GlaxoSmithKline plc (GSK) reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for Nucala (mepolizumab) for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP), a chronic inflammatory disease of the nasal passage linings or sinuses which can lead to nasal polyps and is caused by eosinophils.

This new indication for mepolizumab, which is a monoclonal antibody that targets interleukin-5 (IL-5), 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, according to the company.

The FDA approval of mepolizumab for CRSwNP is based on data from the company's pivotal...

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