(Reuters) – The U.S. Food and Drug Administration has approved Incyte’s eczema cream for children aged between 2 and 11 years, the company said on Thursday.
Wilmington, Delaware-based Incyte is banking on the eczema treatment, called Opzelura, as a key growth driver as it navigates the anticipated loss of exclusivity of its blockbuster blood disorder drug, Jakafi.
The FDA approval was based on results from a late-stage trial, which demonstrated the treatment achieved higher efficacy when compared with a non-medicated cream.
Eczema, or atopic dermatitis, is a skin condition marked by dry, itchy and inflamed patches. It affects an estimated 2-3 million patients aged two to 11 and more than 21 million people 12 years of age and older in the United States, Incyte said.
Opzelura was approved for individuals aged 12 years and older with the disease in 2021, becoming the first topical JAK inhibitor, which blocks inflammation-causing enzymes Janus kinases, to be greenlit in the U.S.
It is now the first of its kind approved for pediatric patients.
Opzelura is also used to treat nonsegmental vitiligo, the most common form of vitiligo which causes symmetrical white patches on the skin.
Sales of Opzelura are expected to double in the next five years from an expected $650 million this year, driven by the FDA and European approvals for the disease in adults and children, CEO Bill Meury said at 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 on Thursday.
Other drugs in the U.S. for children with eczema include topical steroids, Organon’s Vtama, Arcutis’ Zoryve for those six and older, and Sanofi and Regeneron’s blockbuster Dupixent.
(Reporting by Unnamalai L and Puyaan Singh in Bengaluru; Editing by Krishna Chandra Eluri)
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