FDA approves Dupixent for atopic dermatitis in young children
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The FDA has extended the approval of Dupixent to include children aged 6 months to 5 years with moderate to severe atopic dermatitis, Regeneron Pharmaceuticals and Sanofi announced in a press release.
“We’ve had Dupixent now for the past few years, but there are many children who are under 6 who are also suffering from atopic dermatitis,” Amy S. Paller, MD, primary investigator at Northwestern University’s Skin Disease Research Center, told Healio. “It’s been great to have some new studies come out that show it’s just as efficacious and that the safety is the same.”
The approval was based on phase 3 data that found 200 mg or 300 mg of Dupixent (dupilumab), based on body weight, plus low-potency topical corticosteroids resulted in clear or almost clear skin in 28% of patients, compared with 4% of those treated with placebo. Overall disease severity improved by at least 75% in 53% of patients, compared with 11% of placebo-treated patients and a clinically meaningful reduction in itch was achieved in 48% of those treated with Dupixent, compared with 9% of those treated with placebo.
Dupixent is the first biologic approved to treat atopic dermatitis in individuals from infancy to adulthood.
“Until today, treatment options in the U.S. for infants and children under the age of 6 suffering from moderate to severe atopic dermatitis have been limited to topical steroids — which may be associated with significant safety risks when used long-term. This has left patients and their caregivers in desperate need of medicines that can better address the chronic, long-term nature of the disease,” Naimish Patel, MD, senior vice president and head of global development in immunology and inflammation at Sanofi, said in the release. “These young people, and their families, often struggle to cope with the significant impact itch can have not only on the body, but on many other facets of daily life. This approval means that Dupixent, with its well-established safety and efficacy profile, is now available to some of the youngest people living with this disease.”
The drug’s safety profile in this younger age group was similar to the safety profile in the 6 years and older group, with the addition of hand, foot and mouth disease and skin papilloma in patients aged 6 months to 5 years.
“We are not seeing any new red flags, and that means we have a systemic that even though it is injectable, it doesn’t need any lab testing. Safety is what speaks volumes to those of us who treat pediatric patients and certainly to the families of those patients,” Paller said.