European Commission OKs Dupilumab (Dupixent ) for Severe Asthma

Megan Brooks

May 07, 2019

The European Commission (EC) has approved dupilumab (Dupixent, Sanofi/Regeneron) as add-on maintenance therapy for patients aged 12 years or older with severe asthma with type 2 inflammation characterized by increased blood eosinophil levels and/or increased fractional exhaled nitric oxide, whose condition is poorly controlled with high-dose inhaled corticosteroid plus another medicine.

The action follows a recommendation for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use back in March.

Dupixent is already approved in Europe for treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Dupilumab is an interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor; both IL-4 and IL-13 are proteins that stimulate the type 2 inflammation that forms the basis of moderate-to-severe asthma. Dupilumab reduces inflammatory biomarkers including fractional exhaled nitric oxide, immunoglobulin E, and eotaxin-3.

"Type 2 inflammation is responsible for many of the hallmark symptoms of asthma — and Dupixent is the first and only treatment approved for patients in the European Union with severe asthma characterized by multiple biomarkers of type 2 inflammation," George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in a news release.

The EC approved dupilumab for severe asthma based on clinical data from 2888 adults and adolescents who participated in three pivotal trials. In these trials, dupilumab reduced severe exacerbations, improved lung function, and reduced oral corticosteroid use. The most common adverse reaction was injection-site erythema.

Dupixent comes in a 200-mg prefilled syringe for patients with severe asthma or a 300-mg prefilled syringe for those who have severe asthma and are on oral corticosteroids or have comorbid moderate-to-severe atopic dermatitis. It is given as a subcutaneous injection every other week at different injection sites after the initial loading dose. Dupixent can be given in a clinic or at home by self-administration after training by a healthcare professional.

Full prescribing information is available online.

The US Food and Drug Administration approved dupilumab for severe atopic dermatitis in 2017 and as add-on therapy for moderate-to-severe asthma in 2018.

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