Sanofi Announces Licensing of Dupixent® in the EU for Severe Asthma with Type 2 Inflammation

The European Commission (EC) has licensed Dupixent® (dupilumab) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment. The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 4 March 2019.

Patients receiving standard-of-care therapy for severe asthma sometimes have uncontrolled, persistent symptoms. Symptoms can include coughing, wheezing and difficulty breathing, and these patients are at risk of severe asthma attacks that may require emergency department visits or hospitalizations. While ~1% of asthma patients (54,000 in the UK) have a severe, uncontrolled form of asthma, these patients account for substantial asthma-related healthcare resource use and costs. The burden on quality of life is considerable, including frequent exacerbations, life-threatening attacks, and increased comorbidity burden.

"There has been an urgent need to continue investigating new classes of medicines which can treat severe asthma symptoms characterized by type 2 inflammation," said Professor Pavord, Professor of Respiratory Medicine, Nuffield Department of Medicine, University of Oxford. "As one of the lead trial investigators for dupilumab, the results of our clinical trial program 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 license. 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."

Dupixent® (dupilumab) is a human monoclonal antibody that is designed to specifically inhibit overactive signaling 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. In March 2019, the CHMP recommended its license in the European Union for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.

Regeneron and Sanofi jointly develop dupilumab under a global collaboration agreement.

  • <<
  • >>