UK-based pharmaceutical company GlaxoSmithKline’s (GSK; NYSE: GSK) has announced that it has received another indication approval in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now approved as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who do not achieve adequate disease control with systemic corticosteroids and/or surgery.
Previous Approvals and Latest Expansion
Nucala was first approved in China in 2021 for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). In January of the previous year, it received a second approval as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. The latest indication approval is supported by results from the Phase III MERIT and Phase III SYNAPSE studies, which compared the efficacy and safety of Nucala versus placebo in refractory CRSwNP patients in Japan, China, and Russia, as well as more than 400 patients with CRSwNP globally.
Efficacy and Safety of Nucala in CRSwNP Patients
Both studies confirmed that Nucala significantly improved the visual analog scale (VAS) score and endoscopic nasal polyp score of CRSwNP patients with nasal congestion, while maintaining a good tolerability profile. This approval further expands the therapeutic options available for patients with chronic rhinosinusitis and nasal polyps, providing a more effective treatment approach for those who have not responded adequately to other therapies.-Fineline Info & Tech
