Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Wednesday that it has received approval from Japan's Ministry of Health, Labour and Welfare for Nucala (mepolizumab) to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults who are inadequately controlled with standard treatments. Nucala is the first biologic in Japan to offer a four-week dosing schedule for this condition.
CRSwNP affects 1% to 4% of the population, with 40% of cases remaining uncontrolled. The condition is characterised by nasal obstruction, loss of smell, and other symptoms that significantly impact patients' quality of life. While surgery can remove nasal polyps, they often regrow due to underlying inflammation.
Approval of Nucala is based on positive results from the phase III MERIT trial, which demonstrated significant improvements in nasal obstruction and patient quality of life. This marks the third indication for Nucala in Japan for an IL-5 mediated condition, following approvals for asthma and eosinophilic granulomatosis with polyangiitis.
GSK continues to expand its respiratory portfolio, focusing on innovative treatments for a range of respiratory diseases.
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