Sanofi announced that the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody dupilumab (Dupixent) for the treatment of pediatric patients aged 1 to 11 years weighing at least 15 kg (about 33 pounds) with eosinophilic esophagitis. Dupilumab was previously approved for use in patients aged 12 years and older. Experts explained that eosinophilic esophagitis often adversely impacts growth and development and can lead to severe complications. However, the disease is often treated with drugs that aren’t approved by the FDA. The expanded indication for dupilumab—representing the ability to administer earlier treatment in patients with unmet medical needs—came after researchers reported positive outcomes from the two-part phase III EoE KIDS trial. The researchers randomly assigned 61 patients aged 1 to 11 years to receive either tiered dosing regimens of dupilumab based on weight (n = 32) or placebo (n = 29). After a follow-up of 16 weeks, they found that 66% (n = 21) of the patients who received higher doses of dupilumab achieved histologic disease remission compared with 3% (n = 1) of those who received placebo. After a follow-up of 52 weeks, 53% (n = 17) of the patients who received dupilumab and 53% (n = 8/15) of the patients who switched from placebo to dupilumab in the second part of the trial achieved histologic disease remission. The agent was also successful at reducing the number of days in which the patients presented with one or more disease symptoms.