Sanofi’s Dupixent has been approved by the European Commission (EC) as an add-on maintenance treatment for severe asthma in adults and adolescents.
The indication includes patients with Type 2 inflammation characterised by increased blood eosinophils or fractional exhaled nitric oxide (FeNO) that did not experience adequate control with high-dose inhaled corticosteroid (ICS) plus maintenance treatments.
Dupixent is a human monoclonal antibody (mAb) designed to inhibit the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins involved in Type 2 inflammation, which is known to cause specific types of asthma and other allergic diseases.
The inhibition is intended to reduce Type 2 inflammatory biomarkers, including FeNO, immunoglobulin E (IgE) and eotaxin-3 (CCL26).
The EC’s decision was based on results from the LIBERTY ASTHMA programme, which involved a total of 2,888 participants across the Phase III QUEST and VENTURE studies and a Phase IIb study.
Involving 1,902 patients with persistent asthma, QUEST assessed the ability of Dupixent plus standard-of-care therapy to minimise severe exacerbations and improve lung function.
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VENTURE enrolled 210 subjects with severe oral corticosteroid-dependent asthma and assessed if Dupixent plus standard-of-care therapy could cut the use of maintenance oral corticosteroids.
The Phase IIb trial investigated the effect of the combination on lung function. It enrolled a total of 776 adult patients suffering from moderate-to-severe asthma.
Sanofi research and development (R&D) head John Reed said: “In clinical trials, Dupixent not only reduced exacerbations and oral corticosteroid use, but it also improved lung function and patients’ overall quality of life.
“Dupixent offers a new treatment option for those who remain inadequately controlled with current medications, including those dependent on oral corticosteroids, which may have potentially serious side effects when used chronically.”
In partnership with Regeneron, the drug is being assessed in multiple diseases driven by allergic and other Type 2 inflammation.
Dupixent obtained the US Food and Drug Administration (FDA) approval as an add-on maintenance treatment moderate-to-severe asthma in October last year.