Exdensur (depemokimab) approved in China for the treatment of severe asthma

Exdensur is the first and only ultra-long-acting biologic in China for the treatment of severe asthma with an eosinophilic phenotype
Approval based on SWIFT trials showing significantly lower rates of exacerbations in patients receiving depemokimab versus placebo
More than 2 million people in China are affected by severe asthma and experience increased risk of exacerbations requiring hospitalisation

GSK plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.

The approval of Exdensur in severe asthma is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care.¹

Asthma is a major health burden in China affecting an estimated 46 million adults.² Of those, approximately 6% experience severe asthma, which is associated with an increased risk of exacerbations requiring hospitalisation, and higher likelihood of potentially fatal asthma attacks.^2-6 In China, around 15% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months.²

Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

Exdensur is the first and only ultra-long-acting biologic in the EU to treat respiratory diseases
Approval based on four phase III trials with statistically significant and clinically meaningful primary data across severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
An estimated 3 million people live with severe asthma in Europe and patients with CRSwNP face inadequately controlled symptoms

GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Exdensur (depemokimab) in two indications:

as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller;
as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

The approval is based on data from the SWIFT and ANCHOR phase III trials, which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab. Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.^1,2

Asthma affects more than 42 million people in Europe.³ About 5-10% of patients experience severe asthma with many continuing to experience exacerbations and reduced quality of life despite treatment.⁴ In addition, patients with CRSwNP face debilitating daily symptoms and almost half remain uncontrolled.^5,6 Exdensur is a novel therapy that combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing that could address the continued unmet need in these diseases.¹

Exdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps

Exdensur is the first and only ultra-long-acting biologic in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
Approval based on data from the SWIFT and ANCHOR phase III trials showing sustained efficacy in two doses a year versus placebo
Patients with severe asthma face frequent exacerbations, hospitalisations and disease progression, requiring an urgent need for novel solutions

GSK plc (LSE/NYSE: GSK) today announced the approval of Exdensur (depemokimab) by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a treatment for bronchial asthma (limited to severe or refractory patients whose asthma symptoms cannot be controlled with existing treatments) and CRSwNP (limited to patients inadequately controlled with standard treatment).

The MHLW approval was based on data from the SWIFT and ANCHOR phase III trials, which demonstrated the sustained efficacy of a twice-yearly dose of depemokimab versus placebo, both plus standard of care. In SWIFT-1 and SWIFT-2, treatment with depemokimab resulted in significant reductions in asthma exacerbations. Additionally, ANCHOR-1 and ANCHOR-2 showed significant improvements in nasal polyp size and nasal obstruction, two key measures of disease severity.^1,2

Patients in Japan living with severe asthma can experience frequent exacerbations and progression of their disease, leading to hospitalisations and increased overall healthcare costs.^3-6 In addition, patients with CRSwNP face debilitating daily symptoms and almost half remain uncontrolled.^3,7 Depemokimab is a novel therapy that has been developed with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing.¹ These distinct properties could potentially improve patient outcomes while reducing health system burden.

Continue at: https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/

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