A few months after Sanofi and Regeneron’s Dupixent scored a new indication as the first and only medicine to treat eosinophilic esophagitis (EoE) in patients 12 and older, new late-stage trial data show the drug's worth in younger children.
In a phase 3 trial that enrolled kids ages 1 to 11, 68% on a higher dose and 58% of children on a lower dose of Dupixent achieved significant histological disease remission. That compared with just 3% in the placebo group.
With the results, Dupixent becomes the first drug to show positive results in the age group, Sanofi said. The drugmaker and its partner Regeneron plan to submit the data to regulatory authorities “across the world,” starting with FDA submission in 2023.
If approved, Dupixent would be the first treatment for EoE patients under 12.
The trial featured a pediatric EoE sign and symptom questionnaire for caregivers, which the companies said was a “novel endpoint” designed to assess symptoms in young children who might have difficulty verbalizing symptoms on their own.
Investigators shared data from the ongoing trial on Tuesday at the United European Gastroenterology Week.
Approximately 21,000 children in the U.S. in the age group are being treated for EoE, the companies said. About 9,000 of them don’t respond to their current treatment regimen.
The disease is harsh in children and can impact growth, weight gain and development. It can also lead to food-related anxiety that can persist throughout adulthood. Diet adjustments, such as eliminating many foods, is the standard treatment for EoE in children.
Meanwhile, Dupixent is on its way to biopharma superstardom. Sanofi executives recently raised their sales projection to 13 billion euros thanks to strong expected uptake across a range of diseases.
Dupixent just bagged the first U.S. approval for prurigo nodularis and is being studied in other diseases including chronic spontaneous urticaria, hand and foot dermatitis, and choric pruritis of unknown origin.