GlaxoSmithKline’s novel biologic Nucala has picked up an approval in Japan for the treatment of bronchial asthma.
The drug has been licensed for use by the Japanese Ministry of Health, Labour and Welfare (MHLW) for adults and adolescents aged 12 years or older with refractory asthma whose symptoms are inadequately controlled with standard treatment.
Nucala (mepolizumab) is the first of a new class of biologic therapies targeting interleukin-5 (IL-5), which plays a key role in regulating the function of eosinophils, inflammatory white blood cells known to be important in asthma.
The drug’s clearance in Japan comes just four months after a green light in the US, which marked the first of an anti-IL-5 treatment anywhere in the world, and an approval in the EU back in December.
Elsewhere, AstraZeneca’s Tagrisso (osimertinib, AZD9291) was also approved in Japan for the treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy.
Around 30 percent-40 percent of Asian patients with NSCLC have the EGFR mutation at diagnosis. Nearly two out of three patients with NSCLC whose disease progresses after treatment with an EGFR-TKI develop the T790M mutation, for which treatment options are currently limited. Tagrisso targets both these mutations.
“A significant proportion of Japanese patients with lung cancer have the EGFR mutation and about 60 percent of them are likely to develop the T790M resistance mutation following initial TKI treatment. Osimertinib enables us to respond to this disease progression in a precise and logical way as clearly demonstrated in clinical trials, with potential to make a meaningful difference to the lives of Japanese patients,” noted Tetsuya Mitsudomi, Division of Thoracic Surgery, Department of Surgery, Kinki University Faculty of Medicine.