GSK Depemokimab applications accepted for review in China, Japan for asthma with type 2 inflammation, CRSwNP
GSK plc has announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications.
In China, the submitted indications are for an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 and older with type 2 inflammation characterised by blood eosinophil count, and add-on maintenance treatment of adult patients with inadequately controlled CRSwNP. In Japan, the submitted indications are for treatment of severe or refractory bronchial asthma and CRSwNP inadequately controlled with standard treatment.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said, “Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems. Our SWIFT and ANCHOR trials support depemokimab’s potential to suppress IL-5, a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year.”
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