FDA expands Dupixent indication to include moderate-to-severe atopic dermatitis in adolescent patients
Partners Sanofi and Regeneron have both revealed that their jointly developed drug Dupixent (dupilumab) has been authorised by the FDA to expand its approved indications to include the treatment of moderate-to-severe atopic dermatitis in adolescent patients between the age of 12 and 17 whose disease is not adequately controlled with topical prescription therapies.
The FDA’s decision was made under Priority Review, and the drug was also granted Breakthrough Therapy designation by the agency for inadequately controlled moderate-to-severe atopic dermatitis in adolescents.
The ruling was supported by Phase 3 data which demonstrated that Dupixent generated on average a 66% improvement from baseline on the Eczema Area and Severity Index (EASI) after 16 weeks of treatment, compared to 24% with placebo. The drug was also five times more effective in generating disease improvement of at least 75%, with 42% of Dupixent patients achieving this compared to 8% of placebo patients, and ten times more effective in generating clear or almost clear skin, with 24% of Dupixent patients compared to just 2% of placebo patients achieving this.
"For the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash. Today's approval expands the use of Dupixent in the US to include both adults and adolescents with atopic dermatitis or moderate-to-severe asthma," said Dr George D Yancopoulos, President and Chief Scientific Officer at Regeneron. "Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development programme in patients with other type 2 inflammatory diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, where we recently announced positive Phase 3 results and Priority Review of a US regulatory submission, and food and environmental allergies."
Dr John Reed, Head of Research and Development at Sanofi, added: "The approval of Dupixent for adolescents with moderate-to-severe atopic dermatitis means that for the first time these patients and their families, who often help them manage this debilitating disease, will have access to a first-of-its-kind biologic treatment that has already been used to treat approximately 50,000 patients in the US. Our Phase 3 data demonstrated that Dupixent treatment significantly improved skin lesions, reduced itching, and helped clear the skin of these adolescent patients."