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FDA approves Sanofi’s Dupixent for children with dermatitis

Published on 27/05/20 at 12:46pm
Photo by CDC/FDA

The FDA has approved Sanofi’s Dupixent (dupilumab) for children between ages 6 to 11 with moderate to severe atopic dermatitis.

Dupixent is the only biologic medicine approved for this specific population whose disease is not adequately controlled with tropical prescription therapies.

Dupixent is a human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from the trials shows that that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis.

In the trial that led to the drugs approval, more than twice as many children achieved clear or almost clear skin and more than four times the itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone.

Dr John Reed, Global Head of Research and Development at Sanofi, commented on the approval: “This FDA approval is another milestone in the journey for Dupixent as an innovative biologic treatment for atopic dermatitis and other conditions driven in part by type 2 inflammation.

“Caregivers of children with moderate-to-severe atopic dermatitis and their physicians now have access to a first-in-class biologic with a proven safety profile, a factor that often plays a critical role in treatment decisions for younger patients. Additionally, improvements in itch and disease severity were observed as early as two weeks after the first dose and continued throughout active treatment, which is important for these children and their families.”

The FDA had previously granted Breakthrough Therapy designation to the treatment for severe atopic dermatitis in children 6 months to 11 years of age, that could not have their condition controlled on topical prescription medications. This approval was based on a Priority Review which is reserved for medicines that show significant improvements in safety or efficacy in treating serious conditions.

Atopic dermatitis is a chronic inflammatory disease that often appears as a rash on the skin, and more serious forms are characterised by rashes that can potentially cover much of the body and can include intense, persistent itching, skin lesions and skin dryness.

Conor Kavanagh

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