Young children with eczema now have a treatment option to attack the root cause of their itch.
Sanofi and Regeneron’s Dupixent has been approved by the FDA to treat kids between the ages of 6 months and 5 years who suffer from atopic dermatitis and can’t get adequate relief with topical prescription treatments.
Initially approved five years ago for adults with atopic dermatitis, Dupixent becomes the first biologic therapy for young children with the condition. The FDA signed off on its use by adolescents in 2019. A year later, the regulator sanctioned it for kids ages 6 to 11.
“Atopic dermatitis in babies and young children is more than just a rash—the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed,” Julie Block, president and CEO of the National Eczema Association, said in a release. “Caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough.”
Atopic dermatitis is a chronic type 2 inflammatory skin disease, in which more than 85% of patients first develop symptoms before age 5. In the U.S., more than 75,000 children aged 5 years and younger have uncontrolled atopic dermatitis and most are in need of new treatment options.
The FDA based the approval on results from several trials. One phase 3 study of 162 children, which combined Dupixent with low-potency topical corticosteroids (TCS) and compared the combo to TCS plus placebo, showed that Dupixent helped achieve clear skin in 28% as opposed to 4% who were on the TCS.
Additionally, 53% of those on Dupixent showed a 75% or greater improvement in disease severity versus 11% on placebo. And notably, the safety profile with children was similar to that seen with adults.
Also approved for asthma, rhinosinusitis and eosinophilic esophagitis, Dupixent has become one of the most important drugs in the portfolios of both Regeneron and Sanofi. Last year, Dupixent registered sales $5.6 billion, a 53% increase from 2020.