Sanofi has announced the licensing of its human monoclonal antibody, Dupixent (dupilumab).
The approval marks the first biologic licensed in the EU for severe asthma with type II inflammation, as characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO).
The indication is for adults and adolescents 12 years and older as an add on maintenance treatment for severe asthma with type II inflammation who are inadequately controlled with high dose inhaled corticosteroid as well as another product for maintenance.
The European Commission (EC) based the approval on clinical trials in which patients who received Dupixent had significantly lower rates of severe asthma exacerbation than those who received placebo (standard of care), as well as better lung function and asthma control
The drug is designed to specifically inhibit overactive signalling of two key proteins, interleukin-4 and interleukin-13 (IL-4 and IL-13), which are believed to be major drivers of the persistent underlying inflammation in asthma and atopic dermatitis.
“There has been an urgent need to continue investigating new classes of medicines which can treat severe asthma symptoms characterised by type II inflammation,” said Professor Pavord, Professor of Respiratory Medicine, Nuffield Department of Medicine, University of Oxford.
He continued, “As one of the lead trial investigators for dupilumab, the results of our clinical trial programme demonstrate the effect of dupilumab on asthma exacerbations, oral corticosteroid use and overall lung function compared to current standard of care, which is the basis for its new licence. The arrival of this therapy, I believe, offers an important new option for respiratory clinicians to manage their patients.”
Regeneron and Sanofi jointly develop Dupixent under a global collaboration agreement.