Dupixent receives EU approval for children with atopic dermatitis

The marketing authorization for Dupixent has been extended in the European Union to include children ages 6 to 11 years with severe atopic dermatitis, Regeneron and Sanofi announced in a press release.

Dupixent (dupilumab) is the only systemic therapy approved in the EU for children, the release said.

A fully human monoclonal antibody that inhibits IL-4 and IL-13 proteins, Dupixent has previously been approved to treat atopic dermatitis in adults.

“The approval of Dupixent for children in Europe marks another significant milestone for atopic dermatitis patients and their families, broadening the availability of a first-in-class medicine that offers a proven safe and effective treatment for this debilitating skin disease,” John Reed, MD, PhD, global head of research and development at Sanofi, said in the release. “Dupixent’s ability to provide significantly clearer skin and clinically meaningful reduction of persistent itch addresses important unmet needs for these children. In addition to atopic dermatitis, we continue to investigate the potential of Dupixent in younger age groups and across a variety of type 2 inflammatory diseases.”

Dupixent 300 mg is administered as a subcutaneous injection every 4 weeks after an initial loading dose of two injections 14 days apart in children weighing 15 kg to 60 kg. In children who weigh more than 60 kg, Dupixent 300 mg is given every 2 weeks after an initial loading dose administered on the same day.