GlaxoSmithKline (GSK) announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) for use in three additional eosinophil-driven diseases. This marks 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 in Europe.
Both HES and EGPA are potentially life-threatening rare diseases emerging from inflammation in various tissues, which can cause a range of frequently severe symptoms.
Mepolizumab is now the only treatment approved in Europe for use in four eosinophil-driven diseases and is already approved for use in Europe as an add-on treatment for patients aged six years and older with severe eosinophilic asthma (SEA).
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “With millions of patients across Europe affected by eosinophil-driven diseases, we recognise the urgency in delivering the first approved targeted treatment for use in four of these conditions. Today’s approvals reinforce the important role treatments such as mepolizumab can play in helping to improve the lives of patients with these debilitating diseases.”
It is estimated that roughly 7000 people across Europe are affected by EGPA, also known as Churg-Strauss Syndrome, which often affects the lungs and skin, but other organs including the heart, kidneys, nerves and bowels may also be affected. Symptoms include fatigue, muscle and joint pain, and weight loss. Most patients with EGPA are treated with anti-inflammatory corticosteroids or immunosuppressive medicines, which often lead to short and long-term adverse effects. As many as 5,000 adults in Europe are affected by HES, the complications of which range from fever and malaise to respiratory and cardiac problems. The symptoms of HES can grow progressively worse and become life-threatening.
GSK is a global healthcare company committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating to address the unmet needs of this patient group.