Sanofi's Dupixent approved in Europe for severe asthma maintenance

Sanofi has revealed that its interleukin-4 and interleukin-13 (IL-4 and IL-13) inhibitor Dupixent (dupilumab) has been awarded marketing approval by the European Commission as an add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO).

The decision follows a decision from the EC’s Committee for Medicinal Products for Human Use (CHMP) recommending the drug’s use back in March of this year. The therapy is indicated for use in patients over the age of 12 who have seen their condition inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.

The approval was granted based on data illustrating that Dupixent use led to “significantly lower rates of severe asthma exacerbation” and improved lung function and asthma control compared to placebo. The development means that Dupixent is now the first biologic medicine approved in the EU for the aforementioned indication.

“There has been an urgent need to continue investigating new classes of medicines which can treat severe asthma symptoms characterised by type 2 inflammation,” explained Professor Pavord, Professor of Respiratory Medicine at the Nuffield Department of Medicine, University of Oxford. “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.”

Dr Jasmin Hussein, Head of Dermatology and Respiratory at Sanofi Genzyme, also remarked: “We of course welcome the positive EC decision, which is an important milestone for this innovative treatment, first licensed in atopic dermatitis. We are now working closely with the NHS to ensure this treatment is made available to appropriate patients in the UK for whom this treatment is indicated.”

Matt Fellows