FDA Approves Dupixent for Adolescents with Moderate-to-Severe Atopic Dermatitis, Expanding Treatable Patient Population by 50%

March 12, United StatesFDAAnnouncement: Approval Granted for Expanded Indication of Dupixent, a Blockbuster Drug Co-Developed by Regeneron Pharmaceuticals, Inc. and Sanofi, for the Treatment of Patients Aged 12–17 Years with Moderate-to-Severe Atopic DermatitisThe U.S. Food and Drug Administration has announced the approval of an expanded indication for Dupixent (dupilumab), a blockbuster therapeutic co-developed by Regeneron Pharmaceuticals, Inc. and Sanofi. The drug is now approved for the treatment of patients aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or for whom such therapies are not advisable. Dupixent may be administered as monotherapy or in combination with topical corticosteroids.It is estimated that the number of adolescent patients with atopic dermatitis is approximately half that of adult patients. This approval therefore expands the eligible patient population for Dupixent in atopic dermatitis by 50%.

Atopic dermatitis, also known as eczema, is a common chronic inflammatory skin disease. Its clinical symptoms include dry skin, redness, swelling, and itching. In patients with moderate-to-severe atopic dermatitis, the rash may cover most of the body, causing severe and persistent itching. This intense pruritus can impose a significant burden on patients. Atopic dermatitis mostly begins in early childhood. Although symptoms may alleviate in some children as they age, for the majority, the condition persists into adolescence and adulthood.

Dupixent is a targeted biologic therapy that simultaneously inhibits the IL-4 and IL-13 signaling pathways. IL-4 and IL-13 play key roles in type 2 inflammation, which is a major mechanism underlying atopic dermatitis and other severe allergic diseases. Dupixent has received FDA approval for the treatment of adult patients with moderate-to-severe dermatitis. It has previously receivedFDABreakthrough Therapy Designation Granted for the Treatment of Adolescent Patients with Moderate-to-Severe Dermatitis.

This approval is based on Dupixent in pivotal Phase 3Clinical Trialperformance, after 16 weeks of treatment, the mean improvement in Eczema Area and Severity Index (EASI) from baseline was 66% in the Dupixent treatment group versus 24% in the control group. The number of patients treated with Dupixent who achieved complete or almost complete clearance of skin symptoms was more than 10 times that of the control group. Dupixent therapy also significantly alleviated pruritus, with the number of patients experiencing significant relief from itching being seven times that of the control group.

“This approval of Dupixent means that adolescent patients with moderate-to-severe atopic dermatitis can use this unique biologic therapy for the first time. It has been tested in nearly 50,000 patients in the United States,” said Dr. John Reed, Head of Research and Development at Sanofi. “Our Phase 3Clinical Trial"Data show that Dupixent can significantly improve skin lesions in adolescent patients, reduce pruritus, and clear skin symptoms."Bio ValleyBioon.com）