The China National Medical Products Administration has approved GSK’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK, said: “We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed. Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids.”
It is estimated that about 107 million people in China suffer from chronic sinusitis, about 1/3 of whom have chronic sinusitis with nasal polyps. People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge, which can significantly affect their emotional and physical well-being.
CRSwNP is caused by chronic inflammation of the nasal lining that can cause soft tissue growth, known as nasal polyps, that develop in the sinuses and nasal cavity. Up to 80% of patients with CRSwNP have type 2 inflammation, which is associated with more severe disease and nasal polyp recurrence and can be detected by blood eosinophil count, a biomarker measured by a simple blood test. IL-5 is a key cytokine driving this type 2 inflammation and is present at high levels in nasal polyp tissue. Although surgery can be effective at removing polyps, the underlying type 2 inflammation means they have a tendency to regrow.
The approval is based on results of the phase III MERIT trial, which studied the efficacy and safety of mepolizumab over a 52-week period versus placebo in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, and is supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab versus placebo in more than 400 patients with CRSwNP.
Mepolizumab is already approved in China as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis.
