Sanofi Dupixent Blockbuster Drug Gets EU Nod for Children With Asthma

The European Commission has expanded its marketing authorization for Sanofi’s blockbuster drug, Dupixent (dupilumab), as an add-on to maintenance treatment for pediatric patients with severe asthma.

The approval was based on a phase 3 trial with 408 pediatric participants. Those who received the treatment over one year experienced substantially reduced rates of severe asthma, lung function and related quality of life compared to placebo.

Sanofi’s monoclonal antibody targets two immune system cytokines, interleukin 4 and interleukin 13, to prevent inflammation that leads to conditions such as eczema, asthma and nasal polyps linked to sinusitis.

Dupixent was FDA-approved for the treatment of pediatric patients with severe asthma in October 2021. Sales of the drug exceeded $5.7 billion in 2021.