The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended dupilumab (Dupixent, Sanofi-Aventis) as add-on maintenance therapy for patients aged 12 years and older with severe asthma with type 2 inflammation characterized by increased blood eosinophil levels and/or increased fractional exhaled nitric oxide (FeNO) levels whose condition is poorly controlled with high-dose inhaled corticosteroids plus another medicine.
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 severe asthma. Dupilumab reduces inflammatory biomarkers, including FeNO, immunoglobulin E, and eotaxin-3.
"Therapeutic options are limited" for patients with poorly controlled, severe asthma despite adequate therapy, the EMA noted in a press statement. In three clinical trials conducted in 2888 patients, dupilumab was shown to reduce severe asthma exacerbations and improve lung function, the agency said.
The most common side effects of dupilumab are infections, eye disorders (conjunctivitis and related conditions), and injection site reactions.
Dupilumab is already approved in Europe for adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
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.
Detailed recommendations for the use of dupilumab for asthma patients will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be made available after a decision on this change to the marketing authorization has been granted by the European Commission.
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Cite this: EU Panel Backs Dupilumab (Dupixent) for Severe Asthma - Medscape - Mar 04, 2019.
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