Nucala has become the first anti-interleukin-5 therapy approved in China for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP) that cannot be controlled by standard treatments.
This approval marks the third use of Nucala in China for conditions driven by IL-5 mediated inflammation.
Approximately 30 million individuals in China suffer from CRSwNP, which leads to symptoms such as breathing difficulties, sleep issues, and loss of smell.
The Chinese National Medical Products Administration has approved Nucala as an add-on treatment to intranasal corticosteroids for adults with CRSwNP who do not achieve sufficient relief from systemic corticosteroids or surgery.
CRSwNP affects around one-third of the 107 million people in China with chronic sinusitis. This condition can cause nasal blockage, facial pressure, sleep disturbances, nasal discharge, and reduced sense of smell, negatively impacting physical and emotional health.
CRSwNP develops from persistent inflammation in the nasal passages, resulting in the growth of soft tissue polyps in the nasal cavity and sinuses. Up to 80% of individuals with CRSwNP exhibit type 2 inflammation, which can worsen the disease and increase the likelihood of polyp regrowth. Type 2 inflammation can be identified through blood eosinophil levels, which are measured using a standard blood test. Interleukin-5 (IL-5) plays a crucial role in driving this inflammation and is often found in high concentrations within nasal polyps. While surgery can remove polyps, type 2 inflammation can lead to recurrence.
The approval is based on findings from the Phase III MERIT trial, which evaluated Nucala’s efficacy and safety over 52 weeks in patients from Japan, China, and Russia. Additional support came from the global Phase III SYNAPSE study involving over 400 patients with CRSwNP.
In China, Nucala is already approved for treating severe eosinophilic asthma in individuals aged 12 and older, as well as eosinophilic granulomatosis with polyangiitis in adults.
MERIT Trial Overview
The MERIT trial was a randomized, double-blind, placebo-controlled Phase III study spanning 52 weeks. It examined Nucala’s effectiveness in patients with CRSwNP or eosinophilic CRS (ECRS) across Japan, Russia, and China.
The study’s co-primary endpoints focused on:
Changes from baseline in nasal obstruction based on a visual analogue scale (VAS) during weeks 49 to 52 compared to placebo.
Changes in endoscopic nasal polyp scores at week 52 versus placebo.
Among 163 participants (80 in the Nucala group and 83 in the placebo group), Nucala significantly improved nasal obstruction VAS scores, with a mean difference of -1.43 compared to placebo. The nasal polyp score also showed a numerical reduction at week 52, although it did not reach statistical significance.
Secondary endpoints revealed further benefits, including improvements in quality of life measured by the Sino-Nasal Outcome Test (SNOT-22). Patients in the Nucala group also demonstrated significant enhancement in their sense of smell during the final weeks of the trial.
The safety profile of Nucala in this trial aligned with previous studies. Approximately 81% of patients receiving Nucala reported adverse events, compared to 76% in the placebo group. Treatment-related adverse effects occurred in seven patients, but none were classified as severe.
Initially approved in 2015 for severe eosinophilic asthma in the United States, Nucala is a monoclonal antibody that targets and blocks IL-5, a cytokine involved in type 2 inflammation. This therapy has been developed to manage various IL-5 mediated conditions linked to type 2 inflammation.
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