GlaxoSmithKline (GSK) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Nucala (mepolizumab) to treat bronchial asthma patients in the country.
The move follows the approval of Nucala in the US, which was a world first for an anti-interleukin-5 (IL-5) treatment.
Nucala is a monoclonal antibody that stops IL-5 from binding to its receptor on the surface of eosinophils. The inhibition of IL-5 binding reduces blood, tissue and sputum eosinophil levels.
This medicine is administered as a 100mg fixed dose subcutaneous injection, once every four weeks, to treat bronchial asthma in patients with refractory asthma, in addition to their existing respiratory medication.
Nucala will now be made available for adults and adolescents aged 12 years or more in Japan.
GSK Japan president Philippe Fauchet said: "Approval of Nucala not only complements our respiratory portfolio but also gives us the opportunity to make a difference to the lives of more patients in Japan.
"It is our aim to make Nucala available in Japan as soon as possible to support the needs of a significant group of severe asthma patients whose condition is driven by eosinophilic inflammation, which is difficult to control."
The approval from MHLW is based on data from the global clinical development programme, including the pivotal DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) studies which showed efficacy and safety of mepolizumab in patients with severe eosinophilic asthma.
In the phase III MENSA and SIRIUS studies, patients had peripheral blood eosinophil levels greater than or equal to 150 cells/µL at initiation of treatment or greater than or equal to 300 cells/µL within the past 12 months.
Image: GlaxoSmithKline head office in London, UK. Photo: courtesy of Ian Wilson via Wikipedia.