Positive CHMP opinions for GSK’s Nucala in three additional eosinophil-driven diseases

Positive CHMP opinions for GSK’s Nucala in three additional eosinophil-driven diseases

GlaxoSmithKline (GSK) has 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).

If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. 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.

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.

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.”