China Approves GSK's Nucala for CRSwNP

GSK has announced that its drug Nucala (mepolizumab) has received approval from the China National Medical Products Administration (NMPA) for use in adults as an add-on treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication is significant as it expands the uses of Nucala, which is already known for treating IL-5 mediated conditions. This approval provides a new option for patients who have not found relief with systemic corticosteroids or surgery.

The approval by the NMPA is based on positive results from the Phase III MERIT trial, which evaluated Nucala’s safety and effectiveness over a 52-week period. The trial included participants from China, Russia, and Japan. Its outcomes were reinforced by data from the global Phase III SYNAPSE study. The primary endpoints were improvements in nasal obstruction visual analogue scale (VAS) scores and reductions in nasal polyp scores at the end of the study period. The trial, which involved 163 participants, showed that Nucala significantly enhanced nasal obstruction VAS scores and decreased nasal polyp sizes, establishing its efficacy in treating CRSwNP.

Kaivan Khavandi, the global head of respiratory and immunology research and development at GSK, expressed excitement over the approval, highlighting the importance of having a non-surgical treatment option for CRSwNP. This is particularly beneficial for patients who have had to rely on repeated courses of oral corticosteroids, which can have significant side effects over time.

Nucala has a track record of being effective in other eosinophilic conditions. It was previously approved in China for the treatment of severe eosinophilic asthma in both adults and adolescents aged 12 and older, as well as for adults with eosinophilic granulomatosis with polyangiitis. The therapy was first authorized in the United States in 2015 for severe asthma with an eosinophilic phenotype.

Chronic rhinosinusitis is a widespread condition in China, with an estimated 107 million people affected. Among these, about one-third suffer from CRSwNP. This condition is frequently linked to type 2 inflammation and involves elevated levels of interleukin-5 (IL-5) in the nasal polyp tissue. This inflammatory process often leads to the regrowth of nasal polyps after surgical removal, making effective medical treatments crucial.

The availability of Nucala as a treatment option in China offers hope to millions living with CRSwNP, addressing the need for effective alternatives that can manage symptoms and improve quality of life without the need for invasive procedures. This development also highlights the ongoing efforts to expand treatment options for individuals with chronic inflammatory conditions, providing them with better management strategies and improving patient outcomes. Overall, the approval of Nucala for CRSwNP in China marks a significant milestone in addressing unmet clinical needs in this patient population.