GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil-driven diseases

• If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases
• CHMP positive opinions advance efforts to provide the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA) and the first anti-IL-5 biologic treatment for patients with hypereosinophilic syndrome (HES) or chronic rhinosinusitis with nasal polyps (CRSwNP)

GlaxoSmithKline (GSK) plc today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use  in three eosinophil-driven diseases; hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP). The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval decision by the European Commission. 

The three positive opinions are based on data from pivotal studies investigating the role of targeted IL-5 inhibition with mepolizumab in these eosinophil-driven diseases. Eosinophil-driven diseases are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.

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.”

HES and EGPA are both potentially life-threatening rare diseases. Inflammation in various tissues can cause a range of symptoms which are frequently severe. Standard of care for HES and EGPA often includes oral corticosteroids (OCS) and/or cytotoxic immune therapies. The availability of mepolizumab could provide patients with a new treatment option with the potential to improve clinical symptoms and reduce OCS use.

CRSwNP is a condition in which patients develop soft tissue growths called nasal polyps which can cause chronic symptoms such as nasal obstruction, loss of smell and discharge. In severe disease, patients may require repeated surgical intervention due to recurrent growths.

Mepolizumab is already approved for use in Europe as an add-on treatment for patients with severe eosinophilic asthma. Epidemiological, clinical, and pathophysiological studies strongly suggest that CRSwNP and asthma are closely linked and often coexist. Additionally, patients with EGPA frequently have severe asthma.  This overlap across eosinophil-driven diseases underscores the importance of understanding the complex role of eosinophils in disease.

Mepolizumab has been studied in over 4,000 patients in a total of 41 clinical trials evaluating the role mepolizumab may play in targeting the underlying cause of inflammation and reducing eosinophils through IL-5 inhibition. Through ongoing research, GSK is committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating in order to address the unmet needs in this broad patient group.