Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype.- GSK plc.
GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older.
Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved for use in China for adult and adolescent patients with this condition.
Asthma is a major health burden in China affecting an estimated 46 million adults. Of those, approximately 6% experience severe asthma, which confers the most substantial impact on daily living, is associated with an increased risk of exacerbations requiring hospitalisation, and 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.
The approval 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. Adverse events were consistent with the known safety profile for mepolizumab with no new emerging safety issues specific to Chinese patients. The global clinical development programme included four key clinical trials – DREAM9, MENSA10, SIRIUS11 and MUSCA.12 These 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.
The 52-week phase III trial in Chinese patients with severe asthma studied the effect of mepolizumab relative to placebo, as add-on on the primary endpoint of reduction in the annual rate of clinically significant exacerbations (CSE). Patients in the trial who received mepolizumab compared to those who received placebo experienced 65% fewer CSE’s (0.45 vs.1.31 events/year, HR [95% CI]: 0.35 [0.24, 0.50] p<0.001), had a 70% reduction in the frequency of cse per year requiring hospitalisation or emergency department (ed) visits (rr [95% ci] 0.30 [0.12,0.77]; p="0.012)," and a significantly increased period of time before patients experienced the first cse requiring hospitalisation or ed visits (3.4% vs. 12.6%; hr [95% ci]: 0.26 [0.10, 0.69]; p="0.007)."></0.001),>
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