The U.S. Food and Drug Administration has granted approval to Incyte’s eczema cream, Opzelura, for use in children aged 2 to 11 years, the company announced.
The FDA’s authorization was supported by results from a late-stage clinical trial, which showed the treatment delivered greater efficacy compared with a non-medicated cream.
Eczema, also known as atopic dermatitis, is a skin disorder characterized by dry, itchy, and inflamed patches. According to Incyte, it affects roughly 2-3 million children between ages two and 11, and over 21 million individuals aged 12 and older across the United States. Initially approved in 2021 for patients 12 years and older, Opzelura became the first topical Janus kinase (JAK) inhibitor authorized in the U.S., targeting enzymes that trigger inflammation. The new approval for Pediatric Eczema makes it the first JAK inhibitor cleared for younger patients. Opzelura is also indicated for nonsegmental vitiligo, the most prevalent form of the condition, which causes symmetrical white patches on the skin.
Looking ahead, Incyte anticipates Opzelura’s sales will double over the next five years from an estimated $650 million this year, spurred by FDA and European approvals for both adult and pediatric eczema patients, CEO Bill Meury told the Cantor Global Healthcare Conference earlier this month. “We are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option,” Meury said.
In the U.S., other options available for pediatric eczema include topical steroids, Organon’s Vtama, Arcutis’ Zoryve for children aged six and older, and Sanofi and Regeneron’s Dupixent.
