MHLW OKs GSK’s Nucala for Chronic Rhinosinusitis with Polyps

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved GSK’s Nucala (mepolizumab) for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who are not adequately managed with standard therapy. Nucala is a monoclonal antibody targeting interleukin-5 (IL-5).

This approval is underpinned by results from the Phase III MERIT trial, which included participants from Japan, China, and Russia. Additional data from the global Phase III SYNAPSE study further supported the approval. The MERIT trial’s co-primary endpoints were the change from baseline in nasal obstruction visual analogue scale (VAS) score during weeks 49 to 52 compared to placebo, and the alteration in endoscopic nasal polyp score at week 52.

The trial results indicated that mepolizumab significantly improved the nasal obstruction VAS score and showed a numerical reduction in nasal polyp score at week 52. Additionally, improvements in patient quality of life were noted, as assessed by the 22-item Sino-Nasal Outcome Test (SNOT-22), with those treated with mepolizumab experiencing better outcomes compared to those on a placebo. The safety and tolerability data from the trial were consistent with the known profile of mepolizumab.

In Japan, mepolizumab is also approved for treating bronchial asthma in children aged six years and older, as well as in adults with refractory asthma who are not adequately controlled with standard treatments. Furthermore, it is indicated for adult patients with eosinophilic granulomatosis with polyangiitis who do not respond adequately to standard therapies.

Kaivan Khavandi, GSK’s global head and senior vice-president of respiratory/immunology research and development, highlighted the chronic and debilitating nature of CRSwNP and how it often goes underestimated. He noted that this additional indication for Nucala in Japan could offer patients an alternative treatment to surgery or systemic steroids.

This approval in Japan follows GSK’s recent achievement of obtaining approval from the Singapore Health Sciences Authority for a new indication for Jemperli (dostarlimab). Jemperli is now approved for use with chemotherapy in treating advanced or recurrent endometrial cancer.

Nucala’s latest approval provides a new therapeutic option for CRSwNP patients, potentially improving their quality of life and offering a treatment that might help avoid the need for surgery or systemic steroids. This development underscores GSK’s ongoing commitment to addressing unmet medical needs and enhancing patient care through innovative therapies.

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