GlaxoSmithKline plc (GSK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for 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 the first medicine in a new class of anti-interleukin-5 (IL-5) biologic therapies. IL-5 plays an important role in regulating the function of eosinophils, inflammatory white blood cells known to be important in asthma. The medicine is administered as a 100 mg fixed dose subcutaneous injection once every four weeks. Patients will receive the treatment in addition to their existing respiratory medication, which comprises high-dose inhaled corticosteroids plus additional medicines, and may include maintenance oral corticosteroids.

Approval in Japan comes just four months after the approval of Nucala in the US – the first approval of an anti-IL-5 treatment anywhere in the world.

Philippe Fauchet, president, GSK Japan said: “As the market leader in respiratory medicine, GSK has been focused on gaining approval and launching its new respiratory medicines to meet the needs of patients in Japan. 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 MHLW assessment of mepolizumab was based on data from the global clinical development programme, including the pivotal DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) studies, which investigated the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma. All patients in the phase III MENSA and SIRIUS studies 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.

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.

The mepolizumab phase II/III clinical development programme involved nine studies and a total of 915 subjects with severe refractory eosinophilic asthma age 12 years or older who received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration. Three key clinical trials – DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) – have established the efficacy and safety profile of Nucala for these severe eosinophilic asthma patients.

The New Drug Application for Nucala was submitted to the MHLW in May 2015 and was approved on Monday 28th March 2016.   

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. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus. Full US Prescribing Information is available at US Prescribing Information Nucala.   

In the EU Nucala is licensed as an add-on treatment for severe refractory eosinophilic asthma in adult patients. Nucala has also been approved in Canada and Australia. Further regulatory applications have been submitted and are under review in other countries.

Nucala is a registered trade mark of the GSK group of companies.