The FDA has given the green light to Sanofi's drug Dupixent to be used as treatment in pediatric patients with chronic eosinophilic esophagitis, the pharmaceutical company announced Jan. 25.
Dupixent initially received FDA approval in May 2022 for this purpose, but the new approval is an expansion that will allow for the drug to be used in patients between age 1 and 11 years old who weigh at least 33 pounds. Previously, it had only been approved for treatment in children 12 years and older who weigh at least 88 pounds.
This marks the "second disease for which Dupixent is approved in children this young, underscoring the commitment to bringing therapies to young patients with significant unmet needs," the Sanofi news release states.
Eosinophilic esophagitis is a chronic immune system disease that inflames the esophagus and damages its function. The disease is progressive and can impair a child's ability to swallow food, so ongoing treatment and therapies are necessary.
"Young children with eosinophilic esophagitis have significant unmet medical needs; despite existing treatment options, 40% of these children in the U.S. under the age of 12 continue to experience symptoms of this disease," Naimish Patel, MD, the head of global development, immunology, and inflammation at Sanofi said in the release. "Today's approval underscores our commitment to bringing therapies to young patients with unmet needs and also brings hope to these patients who are at a critical age where struggling to eat and maintain weight directly impacts their overall nutritional intake and development."