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The FDA has approved GSK’s Nucala (mepolizumab) as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Mepolizumab is the first anti- interleukin-5 therapy to be approved for CRSwNP, which affects over 5 million in the US, caused by raised eosinophil levels resulting in the formation of nasal polyps. The FDA approval follows the SYNAPSE study showing a reduction in the size of nasal polyps through treatment with mepolizumab.

Article Summary

GSK’s Nucala (mepolizumab) is the first anti-interleukin-5 (IL-5) biologic to have received approval from the FDA as an add-on treatment for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the US.

The FDA’s approval follows the SYNAPSE study, which assessed mepolizumab vs. placebo in over 400 patients. Results demonstrated a significant reduction in the size of nasal polyps and obstruction, showing a 57% reduction in the proportion of patients who had surgery, and a lower proportion needing systemic corticosteroid use, in those treated with mepolizumab vs. placebo.

Affecting over 5 million people in the US, CRSwNP is a chronic inflammatory disease associated with raised levels of a type of white blood cell called eosinophils, which cause soft tissue growth in the form of nasal polyps that can result in chronic symptoms, often requiring repeat surgeries.

“Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities,” said Tonya Winders, CEO, and President of Allergy and Asthma
Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP). “As there have been limited treatment options, particularly for those patients with severe disease, they may rely on oral steroids and recurrent surgery to manage their condition.”

Mepolizumab has been studied in over 4,000 patients across 41 clinical trials. It is also approved as a treatment for patients aged 6 and above with severe eosinophilic asthma, for adults with eosinophilic granulomatosis with polyangiitis (EGPA), and for patients aged 12 and above with hypereosinophilic syndrome (HES).

About Mepolizumab

Developed for the treatment of diseases caused by eosinophilic inflammation, mepolizumab is a monoclonal antibody that reduces blood eosinophils and maintains them at normal levels by preventing IL-5 from binding to receptors on the surface of eosinophils. GSK is a science-led global healthcare company committed to developing treatments for
respiratory diseases. For more information, please visit

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(Source: GSK, 29th July 2021)