GSK Gets Japanese OK for Asthma mAb
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately controlled with standard treatment. Nucala is licensed in Japan for adults and adolescents aged 12 years or older.
Nucala is an anti-interleukin-5 (IL-5) biologic therapy. IL-5 plays an important role in regulating the function of eosinophils, inflammatory white blood cells known to be important in asthma. Nucala is a monoclonal antibody that stops IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.
In the US, Nucala is licensed as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. In the European Union, Nucala is licensed as an add-on treatment for severe refractory eosinophilic asthma in adult patients.