GSK's Nucala has recently received approval in China as an adjunct therapy for adults suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). This significant development was announced following the endorsement from the China National Medical Products Administration, which concluded its approval process based on the favorable results of the phase 3 Merit trial.
This clinical investigation assessed the efficacy and safety of Nucala, also known as mepolizumab, by comparing it to a placebo over a duration of 52 weeks. The outcomes of the study revealed that this monoclonal antibody substantially enhances nasal obstruction, mitigates the loss of smell, and elevates the overall quality of life for CRSwNP patients who were not adequately managed using systemic corticosteroids and/or surgical interventions. Expressing enthusiasm regarding the approval, Kaivan Khavandi, senior vice president and global head of respiratory/immunology research and development at GSK, stated, "We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed.
Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids." This noteworthy approval marks Nucala's third indication for interleukin-5 mediated conditions in China, having previously been authorized as an adjunctive maintenance treatment for patients aged 12 years and older suffering from severe eosinophilic asthma.
Additionally, it has been approved for adults with eosinophilic granulomatosis with polyangiitis, a rare inflammatory disorder. In the United States, Nucala is also sanctioned for treating chronic rhinosinusitis with nasal polyps, severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
Following this announcement, GSK's stocks witnessed a marginal decline in London, as reported on Friday midmorning..