GSK’s Nucala gets regulatory approval in Japan to treat bronchial asthma
pharmafile | March 29, 2016 | News story | Manufacturing and Production, Research and Development | GlaxoSmithKline, Japan, Nucala, US FDA, bronchial asthma
GlaxoSmithKline (LSE: GSK) on Tuesday said the Japanese regulators have approved its drug to treat bronchial asthma.
The Japanese Ministry of Health, Labour and Welfare has granted approval for Nucala (mepolizumab), which is licensed in Japan for adults and adolescents aged 12 years or older, the company said.
GSK Japan president Philippe Fauchet says: “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.”
Nucala, a monoclonal antibody that binds to interleukin-5 (IL-5), is the first medicine in a new class of anti-interleukin-5 biologic. It was granted US regulatory approval in November 2015.
IL-5 plays a key role in regulating the function of eosinophils, white blood cells that increase in number in asthma. It is administered as a 100 mg fixed-dose subcutaneous injection every four weeks.
Anjali Shukla
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