Japanese approval for GSK's Nucala

29 March 2016

UK pharma major GlaxoSmithKline (LSE: GSK) revealed this morning that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Nucala (mepolizumab).

The drug is cleared 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.

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