CHINA—The China National Medical Products Administration (NMPA) has approved GSK’s Nucala (mepolizumab) as an add-on treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults, offering an alternative option for patients struggling with this persistent condition.
The approval marks a significant milestone, making Nucala the third treatment targeting interleukin-5 (IL-5) for IL-5-mediated conditions in China.
CRSwNP is a chronic condition that causes inflammation in the nasal passages and sinuses, often resulting in the growth of nasal polyps.
These polyps can obstruct breathing and lead to other issues, such as frequent sinus infections.
Despite available treatments, many patients continue to struggle with ineffective solutions, including systemic corticosteroids and surgery.
Nucala provides a promising alternative for those seeking relief from this debilitating condition.
The approval is based on the global Phase III SYNAPSE study results and the Phase III MERIT trial, which included participants from China, Russia, and Japan.
These studies demonstrated the efficacy and safety of Nucala in treating CRSwNP.
The 52-week MERIT trial showed that Nucala significantly improved nasal obstruction and reduced the size of nasal polyps, as measured by specific visual and endoscopic scales.
Kaivan Khavandi, Global Head of GSK’s Respiratory/Immunology R&D, expressed his excitement over the approval, emphasizing the need for new, effective treatments for chronic conditions like CRSwNP.
He noted that Nucala offers patients an important non-surgical option and a viable alternative to repeated use of oral corticosteroids.
Nucala has already been approved in China for other conditions, including severe eosinophilic asthma in adults and adolescents over the age of 12 and eosinophilic granulomatosis with polyangiitis.
In 2015, it received approval in the United States for the treatment of severe asthma with an eosinophilic phenotype.
Chronic rhinosinusitis is widespread in China, affecting approximately 107 million people, one-third of whom suffer from the form associated with nasal polyps.
This condition is often linked to type 2 inflammation and elevated levels of IL-5, a protein that plays a key role in developing nasal polyps.
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