European Commission approves Dupilumab for Severe Asthma

European Commission has approved Dupilumab mab for Severe Asthma.

It is the only biologic approved in the EU for severe asthma with type 2 inflammation, as characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO).In clinical trials, Dupilumab (Dupixent) improved lung function and quality of life and reduced severe exacerbations and oral corticosteroid use.

Dupilumab has been approved for a new indication in asthma. It is now approved in the European Union (EU) 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.

"People whose severe asthma is inadequately controlled on current therapy continue to have trouble breathing and suffer potentially life-threatening exacerbations. This daily burden and unpredictability can significantly diminish quality of life, causing missed days of school, work and social activities," said Tonya Winders, President, Global Allergy and Asthma Patient Platform (GAAPP). "GAAPP welcomes the addition of new treatments such as Dupixent, designed to help those with severe asthma take control of their symptoms and get on with their daily lives."

Despite standard-of-care treatment, people with severe asthma often have inadequately controlled, persistent symptoms that may make them suitable for treatment with biologic therapy. These patients live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. In addition to taking maintenance ICS treatment, patients with severe asthma often rely on oral corticosteroids (OCS) when their symptoms worsen. While OCS treatment can provide relief for severe symptoms, current asthma guidelines suggest limiting their chronic use to the most severe patients due to the potential for serious side effects.

"Type 2 inflammation is responsible for many of the hallmark symptoms of asthma – and Dupilumabi the first and only treatment approved for patients in the European Union with severe asthma characterized by multiple biomarkers of type 2 inflammation," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Dupixent is now approved in asthma and atopic dermatitis, and we continue to study this novel treatment in younger populations with these diseases, as well as other conditions driven by type 2 inflammation, including chronic rhinosinusitis with nasal polyps and food and environmental allergies."

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, immunoglobulin E (IgE) and eotaxin-3 (CCL26).

"Today's approval marks an important moment for adolescents and adults in the European Union who suffer from severe asthma with type 2 inflammation," said John Reed, M.D., Ph.D., Head of Research and Development at Sanofi. "In clinical trials, Dupilumab (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."