FDA Approves Blockbuster Anti-inflammatory Drug for Infants with Eczema

Today, Regeneron and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of pediatric patients with moderate-to-severe atopic dermatitis aged 6 months to 5 years . Their condition was not adequately controlled after topical therapy or was not suitable for use with these therapies. Dupilumab is the first biological product approved for the treatment of infants to adults with moderate to severe atopic dermatitis, according to the press release.

Atopic dermatitis, also known as eczema, is a chronic type 2 inflammatory skin disease that occurs in 85 to 90% of patients before age 5 and often persists into adulthood. Symptoms include intense, persistent itching and skin lesions that cover most of the body, leading to dry, cracked, painful, red or darkened skin, crusting and bleeding, and an increased risk of skin infections. Moderate-to-severe atopic dermatitis may also significantly affect the quality of life of young children, their parents, and caregivers. The current treatment option for this age group is primarily topical corticosteroids (TCS), which may have safety risks and may impair normal growth with long-term use.

Dupilimumab is a fully humanized monoclonal antibody that selectively inhibits the interleukin 4 (IL-4) and interleukin 13 (IL-13) signaling pathways, reducing the pathological response of type 2 inflammation, from Mechanistically treat type 2 inflammation-related diseases, such as asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis.

The approval is based primarily on data from a Phase 3 clinical trial. In this trial, infants and young children were treated with dupilumab and low-intensity TCS, or TCS alone. The trial results showed that at week 16, the dupilumab + TCS group:

Complete or near complete clearance of skin symptoms in 28% of patients compared to 4% in the control group

53% of patients achieved >75% improvement in disease severity from baseline compared to 11% in the control group

Clinically meaningful reduction in pruritus was achieved in 48% of patients compared to 9% in the control group

The safety profile observed in children 6 months to 5 years of age was similar to that observed in children over 6 years of age with atopic dermatitis.

"Previously, treatment options for children under 6 years of age with moderate-to-severe atopic dermatitis in the United States were limited to topical steroids. Its long-term use is associated with significant safety risks. Patients and their families desperately need better medicines." Dr. Naimish Patel, global development head of immunology and inflammation at Novi, said, "These infants and their families often have difficulty coping with the effects of itch on their bodies and in every aspect of their daily lives. Today's approval means that dupilumab It can benefit some of the youngest patients."