The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval for GlaxoSmithKline’s Nucala (mepolizumab) in three additional eosinophil-driven diseases.
Nucala, a monoclonal antibody (mAb) that targets interleukin-5 (IL-5), has received positive opinions recommending approval in Europe for use in hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP).
HES and EGPA are potentially life-threatening rare diseases that cause inflammation in various tissues. The range of symptoms for these conditions can vary and are often severe.
Meanwhile, CRSwNP is characterised by the development of soft tissue growths (nasal polyps) which can cause nasal obstruction, loss of smell and discharge. In severe cases, patients can require repeated surgical intervention due to recurrent growths.
In Europe, Nucala is already approved for use as an add-on treatment for patients with severe eosinophilic asthma.
“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,” said Christopher Corsico, senior vice president, Development at GSK.
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,” he added.