GSK : Nucala Approved In China For Severe Asthma Treatment With Eosinophilic Phenotype

(RTTNews) - GSK plc (GSK, GSK.L) said that the China National Medical Products Administration has approved Nucala or 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.

The approval was based on a separate Phase III trial among Chinese patients, reinforcing the efficacy and safety data of mepolizumab.

This is the second indication for mepolizumab in China, with approval for use in adults with eosinophilic granulomatosis with polyangiitis or EGPA received in 2021. Epidemiological, clinical and pathophysiological studies show that patients with EGPA usually also have asthma, which is often severe.

Asthma is a major health burden in China affecting an estimated 46 million adults. In China, 15.5% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months.

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