Sanofi-Aventis Korea has confirmed the safety and efficacy profile of Dupixent (ingredient: dupilumab) in treating children with uncontrolled moderate-to-severe atopic dermatitis in recent studies.
The company conducted phase 2/3 LIBERTY AD PRESCHOOL clinical trials with 162 patients aged six months to five years.
In the phase 3 study, Sanofi-Aventis Korea found that a combination of Dupixent and low-dose topical corticosteroids (TCS) improved disease severity, skin lesions, and quality of life compared to TCS monotherapy at the 16th week.
During the study, 28 percent of patients administered with Dupixent met the primary endpoint, showing no or few lesions, while only four percent reached the primary endpoint in the placebo group.
Outside the U.S., the proportion of patients showed 75 percent or greater improvement in the Eczema Severity Index (EASI), the co-primary endpoint, was 53 percent in the Dupixent group and 11 percent in the placebo group.
“Children get significantly impacted during their childhood when they are diagnosed with moderate-to-severe atopic dermatitis in the first few months of life, and their parents and caregivers are challenged to find safe and effective treatment options,” said Dr. John Reed, the global head of Research and Development at Sanofi.
Dr. Reed added that as the standard care for children with atopic dermatitis could damage skin and potentially impact their growth if used for long-term, the company was encouraged by the results of the recent studies showing how Dupixent demonstrated the potential as a new option for very young patients.
“When starting the clinical trials, more than half of patients’ bodies were covered with the disease, and nearly one-third of them had a history of using immunosuppressive medicines,” Regeneron’s President and CSO George D. Yancopoulos said. “Our data showed that Dupixent dramatically reduced the impact of atopic dermatitis in young children and their family by rapidly improving symptoms and outcomes.”
Sanofi plans to present the detailed study results at medical conferences and submit them to regulatory authorities in each country.
The Ministry of Food and Drug Safety has yet to approve Dupixnet for patients aged six months to five years.