Dupixent licensed in the EU for severe asthma with type 2 inflammation

The European Commission (EC) has licensed Dupixent (dupilumab), developed by Regeneron and Sanofi, for older than 12 patients as an add-on maintenance treatment for severe asthma with type 2 inflammation with raised blood eosinophils and fractional exhaled nitric oxide (FeNO).

Sanofi said the decision from the EC comes after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) from March this year.

In clinical trials, patients who received Dupixent (dupilumab) 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, Sanofi said.

Professor Pavord from Oxford was quoted as saying in the press release: “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.”

Dupilumab is a human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that play a central role in type 2 inflammation that underlies specific types of asthma as well as several other allergic diseases. This effect is associated with the reduction of type 2 inflammatory biomarkers including FeNO and immunoglobulin E (IgE).

“We of course welcome the positive EC decision, which is an important milestone for this innovative treatment, first licensed in atopic dermatitis,” said Dr Jasmin Hussein, Head of Dermatology and Respiratory, Sanofi Genzyme. “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.”