GSK has announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala (mepolizumab) for use in adult patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP), specifically those who do not respond adequately to standard treatments.
Nucala is now the first and only biologic in Japan available with a four-weekly dosing regimen for this condition.
CRSwNP is a long-term condition affecting 1% to 4% of the general population, with 40% of those affected having a form of the disease that is difficult to control. Patients with CRSwNP often endure symptoms such as blocked nasal passages, a loss of sense of smell, facial discomfort, sleep disturbances, and nasal discharge, all of which can severely impact their quality of life. In Japan, about 2 million people are affected by chronic rhinosinusitis, and around 200,000 of them require surgery due to nasal polyps.
CRSwNP arises from ongoing inflammation in the nasal passages, leading to the formation of soft tissue growths known as nasal polyps within the sinuses and nasal cavities. A significant majority of CRSwNP patients (over 80%) have type 2 inflammation, which is linked to more severe disease and a higher likelihood of nasal polyp recurrence. Interleukin-5 (IL-5) is a crucial cytokine that drives type 2 inflammation and is found at elevated levels in nasal polyp tissue. Although surgery can be effective in removing polyps, the underlying type 2 inflammation often causes them to grow back.
The approval of Nucala in Japan is supported by the results of the phase III MERIT trial, which evaluated the efficacy and safety of mepolizumab over a 52-week period in patients from Japan, China, and Russia with CRSwNP that could not be adequately controlled with existing treatments. Additionally, data from the global phase III SYNAPSE study, which compared the effects of mepolizumab and a placebo in over 400 CRSwNP patients, further supported the approval.
Mepolizumab is already approved in Japan as a treatment for bronchial asthma in children aged 6 years and older, as well as in adults with refractory asthma that remains uncontrolled by standard therapies. It is also approved for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) who do not respond sufficiently to standard treatments.
About the MERIT Trial
The phase III MERIT trial focused on two primary endpoints: the change from baseline in the nasal obstruction visual analogue scale (VAS) score during weeks 49 to 52 compared to a placebo, and the change in the endoscopic nasal polyp score at week 52 compared to a placebo.
The trial showed that treatment with mepolizumab significantly improved the nasal obstruction VAS score and was linked to a numerical reduction in nasal polyp score at week 52. Improvements in patient quality of life were also observed with mepolizumab treatment, as measured by the Sino-Nasal Outcome Test (SNOT-22).
Safety and tolerability results were consistent with the known profile of mepolizumab, with similar proportions of patients in both the mepolizumab and placebo groups experiencing adverse events during treatment.
About Nucala (mepolizumab)
First approved in the United States in 2015 for the treatment of severe asthma with an eosinophilic phenotype, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key cytokine involved in type 2 inflammation.
IL-5 is critical to the development, maturation, and activation of eosinophils, a type of white blood cell that plays a significant role in the pathogenesis of asthma and CRSwNP. Research indicates that IL-5 also affects other cell types beyond eosinophils, contributing to inflammation in airway diseases. Mepolizumab works by binding directly to IL-5 molecules and inhibiting their activity. The drug has been developed for treating a range of IL-5 mediated diseases associated with type 2 inflammation.
コメント