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CHMP recommends GSK’s Nucala (mepolizumab) for three eosinophil-driven diseases

Published on 22/09/21 at 11:59am

 

GlaxoSmithKline (GSK) has announced that the Committee for Medicinal Products for Human Use (CHMP) has issued positive feedback on the use of Nucala (mepolizumab) in providing the first targeted treatment for three eosinophil-driven diseases. These consist of eosinophilic granulomatosis with polyangiitis (EGPA) , hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP).

Eosinophil-driven diseases are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.

Patients with CRSwNP develop soft tissue growths called nasal polyps, which can cause chronic symptoms including nasal obstruction, loss of smell, and discharge. In severe cases, surgical intervention due to recurrent growths may be required.

HES and EGPA both have the potential to be life-threatening rare diseases. Symptoms are frequently severe, and can be triggered by inflammation in various tissues. Current treatment for these diseases includes oral corticosteroids (OCS) and or/or cytotoxic immune therapies.

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Mepolizumab is a monoclonal antibody that targets interleukin-5 (IL-5), and has been studied in over 4,000 patients in a total of 41 clinical trials evaluating its role in targeting the underlying cause of inflammation and reducing eosinophils.

It could potentially improve clinical symptoms and reduce OCS use, and, if approved for use in Europe, it would be the only treatment indicated for use in the three diseases. Research studies strongly suggest that CRSwNP and asthma are closely linked, and patients with EGPA also frequently have severe asthma.

Christopher Corsico, Senior Vice President Development, GSK said: “We are pleased with the CHMP’s positive opinions as there are currently limited targeted treatment options available for patients in Europe with eosinophil-driven disease. If approved, mepolizumab would be the first targeted treatment available for use in four of these diseases and would further reinforce its role in targeting the underlying cause of inflammation.”

Lina Adams

 

 

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