FDA approves Dupixent for atopic dermatitis in children

Dupixent has been approved by the FDA for the treatment of moderate to severe atopic dermatitis in children aged 6 to 11 years, Regeneron Pharmaceuticals and Sanofi announced in a press release.

A fully human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 proteins, Dupixent (dupilumab) previously was granted breakthrough therapy designation for the treatment of severe AD in children.

It is prescribed in two doses based on weight: 300 mg every 4 weeks for children between 15 kg and 30 kg and 200 mg every 2 weeks for children between 30 kg and 60 kg.

“This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate to severe atopic dermatitis. This young, vulnerable population struggles with debilitating symptoms and disease covering over half of their body, impacting them and their families who spend countless hours helping them manage their disease,” George D. Yancopoulos, MD, PhD, co-founder, president and chief scientific officer at Regeneron, said in the release.

The approval was based on pivotal phase 3 data in which Dupixent combined with topical corticosteroids was compared with topical corticosteroids alone. Significant improvements in disease severity, skin clearance and itch were seen in those treated with the combination therapy.