CHINA – China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older.
Developed by GSK plc, Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved for use in China for adult and adolescent patients with this condition.
The NMPA authorization targets patients diagnosed with asthma, which is a major health burden in China affecting an estimated 46 million adults.
In a news release, Kaivan Khavandi, Senior Vice President and Global Head of Respiratory and Immunology for GSK’s Research and Development Department (R&D), said: “We are delighted with this approval, supported by evidence in a Chinese population.”
It is important to note that severe asthma requires treatment with high-dose inhaled corticosteroids plus a second controller to prevent it from becoming uncontrolled despite this therapy.
Of the estimated 46 million adults, approximately 6% experience severe asthma, which confers the most substantial impact on daily living.
Severe asthma is associated with an increased risk of exacerbations requiring hospitalization and a higher likelihood of potentially fatal asthma attacks.
In China, 15.5% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months.
“Millions of people in China with severe eosinophilic asthma can now potentially benefit from the advance in management that GSK’s Nucala could offer,” Kaivan Khavandi affirmed the Chinese population.
Moreover, guidelines for bronchial asthma prevention and management from the Asthma group of the Chinese Thoracic Society reference the current unmet need among Chinese patients with this condition.
The 2020 edition of these guidelines reference evidence for targeted biologic therapy that could reduce exacerbations, emergency or hospitalization rates, oral corticosteroid use, and also improve asthma control and lung function.
Bearing this in mind, the NMPA approval of GSK’s Nucala for use in severe asthma is based on positive data from a separate phase III trial among Chinese patients.
The results from the Chinese study reinforce existing data for mepolizumab in patients with severe asthma.
The Chinese study reveals adverse events were consistent with the known safety profile for mepolizumab with no new emerging safety issues specific to Chinese patients.
Additionally, the global clinical development programme included four key clinical trials, including DREAM9, MENSA10, SIRIUS11, and MUSCA.
The four key clinical trials established the efficacy and safety profile of mepolizumab in patients with severe asthma with an eosinophilic phenotype with safety data coming from pivotal, long-term, and real-world studies.
Meanwhile, the 52-week phase III trial in Chinese patients with severe asthma studied the effect of mepolizumab relative to placebo, as an add-on on the primary endpoint of reduction in the annual rate of clinically significant exacerbations (CSE).
Patients in the phase III trial who received mepolizumab compared to patients who received placebo experienced 65% fewer CSE’s.
The patients had a 70% reduction in the frequency of CSE per year requiring hospitalisation or Emergency Department (ED) visits, and a significantly increased period of time before patients experienced the first CSE requiring hospitalization or ED visits.
Furthermore, mepolizumab is the first anti-IL-5 targeting biologic approved in China, marking an important medical advance in the management of asthma.
IL-5 is an inflammatory signaling molecule that is central to the development, maturation, and activation of eosinophils, a type of white blood cell implicated in the pathogenesis in the majority of cases of severe asthma.
For this reason, GSK has received the second indication for mepolizumab in China, with approval for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA) received in 2021.
In addition to being approved in China for use in adults with eosinophilic granulomatosis with polyangiitis, Nucala was included on the National Reimbursement Drug List in January 2023.
On the NMPA approval, he underscored: “This is a testament to GSK’s ongoing commitment to redefine respiratory disease management globally.”