Sanofi and Regeneron Announce Positive Phase 3 Data for Dupixent in Infants and Young Children with Moderate-to-Severe Atopic Dermatitis

Compiled by Aspirin

On December 13, Eastern Time, Sanofi and Regeneron disclosed positive data from the Dupixent Phase III trial Liberty Ad Preschool. When used in combination with topical corticosteroids, the current standard treatment, Dupixent demonstrated significantly superior results compared to placebo in skin improvement, symptom clearance, overall disease severity, and itch relief among children aged 6 months to 5 years with moderate to severe atopic dermatitis.

This disclosure has further solidified Sanofi and Regeneron's Dupixent on its path to becoming a blockbuster drug with sales of up to 10 billion US dollars. The drug has already been approved for the treatment of eczema in children aged 6 years and above, significantly boosting its sales. With positive trial data in children and infants, this antibody drug appears poised for another sales increase soon.

Sanofi stated as early as August 2021 that Dupixent had achieved all primary and secondary endpoints in a clinical trial involving 162 patients. During the latest session of the 2021 Revolutionizing Atopic Dermatitis Conference (RAD 2021), the data disclosed by Sanofi demonstrated the robust clinical performance of Dupixent.

Improvement in Overall Symptoms: In the trial, 28% of patients using Dupixent in combination with corticosteroids achieved complete or near-complete clearance of skin symptoms by week 16, compared to only 4% in the placebo group. These results were sufficient for the clinical trial to meet its primary endpoint. During the same period, 53% of patients on Dupixent showed a 75% or greater improvement in overall disease severity (a co-primary endpoint outside the U.S.) from baseline, compared to 11% in the control group.

Itch: Compared with baseline, patients in the Dupixent group experienced an average improvement of 49% in itch, while the placebo group saw a 2% improvement. The overall disease severity in Dupixent patients improved by an average of 70% from baseline, compared to a 20% improvement in the placebo group.

Safety: Sanofi stated that regarding the safety in the trial, the safety of relatively older children was comparable to that of adolescents and adults. The overall adverse event rate was 64% in the Dupixent group and 74% in the control group.

Sanofi and Regeneron will use these data to seek approval from regulatory authorities in various countries for Dupixent in children aged 6 months to 5 years. Sanofi plans to submit an application in the United States in 2021 and begin submissions in the European Union in the first half of 2022. Sanofi said that Dupixent is the first biologic to show positive results in such a young patient population.

Dupixent, the Rising Star: Regeneron reported last month that global sales of the drug surged 55% in Q3 2021 to $1.66 billion, compared to approximately $1.07 billion for the same period in 2020. In the first nine months of this year, Dupixent’s global revenue reached about $4.42 billion, versus $2.87 billion during the same period in 2020.

Sanofi’s leadership predicted earlier this year that, with its strong data across five indications, Dupixent’s peak sales are very likely to exceed €10 billion. This is about twice the current annual sales of this monoclonal antibody drug.

At the same time, Sanofi stated that due to the positive data from chronic spontaneous urticaria, prurigo nodularis, eosinophilic esophagitis, and infantile atopic dermatitis, the future label expansion prospect of Dupixent will also be bright.

Reference Source: Sanofi, Regeneron Plan Dupixent Filing in Young Eczema Patients, Advancing Drug's Megablockbuster Ambitions