FDA greenlights Dupixent for children with moderate-to-severe asthma

The US Food and Drug Administration has approved Dupixent (dupilumab) as an add-on maintenance treatment of patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Dupixent, which is marketed by France’s Sanofi (Euronext: SAN) and Regeneron (Nasdaq: REGN), generated full-year 2020 revenues of 3.5 billion euros ($4.1 billion), and 1.24 billion euros, up 57%, in the second quarter of this year, and Sanofi has an ambitious target of up to $12 billion in peak annual sales.

Asthma is one of the most common chronic diseases in children. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing, which could impact them through adulthood. Long-term use of systemic corticosteroids can carry significant risks.