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.”
Depemokimab, a monoclonal antibody that targets interleukin-5 (IL-5), is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions. Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results from the SWIFT and ANCHOR trials. In asthma patients and patients with CRSwNP, these trials showed depemokimab could offer sustained inhibition of a key driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year.1-3 Longer intervals between doses have been shown to overcome barriers to optimal care such as patient adherence.4
IL-5 is a key cytokine (protein) in type 2 inflammation. Type 2 inflammation is typically identified by blood eosinophil count and is an underlying driver in many diseases. This type of inflammation is present in the majority of patients with difficult to treat asthma and can lead to exacerbations and hospitalisation. Type 2 inflammation is also present in up to 80% of people with CRSwNP and is associated with more severe disease and symptoms.
Asthma is a major health burden in China affecting an estimated 46 million adults with approximately 15.5% reporting to have experienced an exacerbation requiring a hospital visit in the last 12 months.
CRSwNP is a chronic condition that affects up to 4% of the general population, of whom 40% have uncontrolled disease. It is estimated that about 107 million people in China suffer from chronic sinusitis, about 1/3 of whom have chronic sinusitis with nasal polyps. In Japan, it is estimated that there are 2 million people with chronic sinusitis, of which about 200,000 are subject to surgery due to nasal polyps.
Depemokimab is currently not approved in any country.
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