GlaxoSmithKline announced that, Japanese Ministry of Health, Labor and Welfare Has accepted the new drug Nucala (mepolizumab).This is a monoclonal antibody against interleukin 5 And for the treatment of chronic sinusitis with nasal polyps in adult patients.
The request is based on the results obtained from Pivotal Phase III MERIT Trial, who studied the efficacy and safety of mepolizumab in patients with chronic eosinophilic sinusitis in Japan, China, and Russia over a 52-week period.The primary endpoint was change from baseline in score endoscopic nasal polyps Totals at week 52 and changes in the Visual Analog Scale (VAS) for nasal congestion in the 4 weeks preceding the final week.
Sinusitis is caused by chronic inflammation of the nasal mucosa, which can cause symptoms such as nasal congestion, loss of smell, facial pressure, sleep disturbance, and runny nose.
Numerically, Japan is estimated to have 2 million people have chronic sinusitis, about 200,000 of them underwent surgery for nasal polyps. Specifically, the disease is caused by chronic inflammation of the lining of the nasal passages, causing symptoms such as nasal congestion, loss of smell, facial pressure, sleep disturbance and runny nose.
According to GlaxoSmithKline, surgery may be suitable for serious caseHowever, polyps have a tendency to recur, often requiring further surgery. Therefore, a treatment like the one proposed by the British company is needed.
Mepolizumab is currently approved in Japan for the treatment of bronchial asthma in children 6 years and older and in adults with refractory asthma whose symptoms are not adequately controlled, and if approved in adult patients, it would be first treatment For this disease in this age group.