GSK’s Nucala Approved in China for Treatment of Adults with Chronic Rhinosinusitis with Nasal Polyps

GlaxoSmithKline (GSK) has announced that its biologic treatment, Nucala (mepolizumab), has received approval from China’s National Medical Products Administration (NMPA) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This approval marks a significant step in expanding the availability of Nucala to a broader patient population in China, offering a new treatment option for individuals suffering from this debilitating condition.

Chronic rhinosinusitis with nasal polyps is a severe inflammatory disease characterized by the growth of non-cancerous polyps in the nasal and sinus cavities. These polyps can cause persistent symptoms, including nasal congestion, loss of smell, sinus pressure, and recurrent sinus infections. The condition often leads to a substantial reduction in quality of life and can be difficult to manage with conventional treatments.

Nucala, an interleukin-5 (IL-5) antagonist monoclonal antibody, has been previously approved for several respiratory conditions, including asthma and eosinophilic granulomatosis with polyangiitis (EGPA). The approval for CRSwNP adds to its growing list of indications, underscoring its efficacy in targeting the underlying inflammatory processes of the disease.

GSK’s President of Global Pharmaceuticals, Luke Miels, commented on the approval: “This milestone is a significant achievement for patients living with CRSwNP in China, who often face a long and challenging journey to control their symptoms. Nucala offers a promising new treatment option for those who are not adequately managed by current therapies.”

The approval of Nucala for CRSwNP in China was based on data from clinical trials demonstrating that the drug significantly reduced the size of nasal polyps and improved symptoms related to the disease. These results underscore Nucala’s potential as a key therapeutic option for managing chronic rhinosinusitis with nasal polyps, particularly for patients who experience severe or refractory disease.

Nucala will now be available for use in China, with GSK working closely with healthcare providers to ensure access to this innovative therapy. The company also plans to continue its efforts in educating both physicians and patients on the benefits of targeted biologic treatments for chronic rhinosinusitis with nasal polyps.

For further information about Nucala, including its full prescribing information, patients and healthcare providers can visit GSK’s official website or consult with their healthcare professionals.

This approval is the latest in a series of regulatory achievements for GSK’s respiratory portfolio, which includes treatments for asthma, COPD, and other chronic respiratory conditions.