GSK has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), to treat adult patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP) who do not respond adequately to standard therapies.
Nucala is the first and only biologic available in Japan with a four-week dosing regimen for this condition.
CRSwNP is a chronic condition affecting 1% to 4% of the population, with around 40% of those affected having uncontrolled symptoms. This condition significantly impacts patients' quality of life, causing nasal blockage, loss of smell, facial pressure, disturbed sleep, and nasal discharge, all of which take a toll on physical and emotional well-being. In Japan, approximately 2 million people suffer from chronic rhinosinusitis, and around 200,000 of them undergo surgery to remove nasal polyps.
The underlying cause of CRSwNP is persistent inflammation of the nasal lining, which can lead to the formation of nasal polyps, soft tissue growths in the sinuses and nasal cavities. Over 80% of CRSwNP patients exhibit type 2 inflammation, which is linked to more severe symptoms and a higher likelihood of nasal polyp recurrence. IL-5 plays a critical role in driving this type of inflammation and is found in elevated levels within nasal polyps. While surgical removal of polyps is often effective, the inflammation driving their growth remains, leading to frequent regrowth.
The MHLW's approval is supported by the results from the phase III MERIT trial, which evaluated the safety and effectiveness of mepolizumab over 52 weeks in patients from Japan, China, and Russia with inadequately controlled CRSwNP. This approval is further backed by data from the global phase III SYNAPSE study, which compared mepolizumab to a placebo in over 400 CRSwNP patients.
Nucala has already been approved in Japan for treating bronchial asthma in children aged six and older and in adults with refractory asthma unresponsive to standard treatments. It is also approved for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) who do not respond adequately to standard therapies.
Details of the MERIT Trial
The phase III MERIT trial focused on two primary endpoints:
the change in nasal obstruction visual analogue scale (VAS) score during weeks 49 to 52 compared to placebo,
the change in endoscopic nasal polyp score at week 52 compared to placebo.
The results showed that treatment with mepolizumab led to significant improvements in the nasal obstruction VAS score (mean treatment difference: -1.43) and a numerical reduction in nasal polyp score at week 52. Patients also reported better quality of life, as indicated by the 22-item Sino-Nasal Outcome Test (SNOT-22), when treated with mepolizumab compared to placebo.
The safety and tolerability of mepolizumab were consistent with its established profile, with a similar proportion of patients in both the mepolizumab and placebo groups experiencing adverse events during treatment. Seven patients experienced treatment-related adverse events, none of which were classified as serious.
Overview of Nucala (mepolizumab)
First approved in 2015 for severe eosinophilic asthma in the U.S., mepolizumab is a monoclonal antibody that targets IL-5, a cytokine crucial for type 2 inflammation. IL-5 is key to the growth, maturation, and activation of eosinophils, a type of white blood cell that contributes to the development of asthma and CRSwNP. Research suggests that IL-5 also affects other cells involved in airway inflammation. Mepolizumab binds to IL-5 molecules, inhibiting their action. It has been developed to treat various IL-5-mediated conditions associated with type 2 inflammation.
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