Incyte’s eczema cream now approved for pediatric treatment

September 29, 2025 9

WILMINGTON — Incyte Corporation has secured its third U.S. Food and Drug Administration approval for its eczema cream, expanding its use for children.

Delaware’s rising biopharmaceutical company has made its name on cancer treatments. But with the exclusive rights to Jakafi expiring in 2028, Incyte is looking to bank on Opzelura as its next success story.

Opzelura, a cream-version of ruxolitinib, was approved to be used for eczema in patients between ages 2 and 11 with mild to moderate symptoms, the company announced earlier this month. The U.S. FDA approved the drug on data from a clinical trial that demonstrated higher efficacy with a non-medicated cream.

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“With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option with the potential to significantly improve the burdensome symptoms they experience every day,” Incyte CEO Bill Meury said in a prepared statement. “This approval is another step toward addressing the real-world challenges faced by patients suffering from chronic skin conditions, including people living with atopic dermatitis.”

Eczema, or atopic dermatitis, is a skin condition that has symptoms like patches of dry, itchy or inflamed skin. It impacts more than 21 million people, including at least 2 million pediatric patients.

Incyte representatives said that conversations with those in the topic dermatitis community highlighted a need for more treatment options for younger children, particularly with management of symptoms for young patients.

Opzelura was first approved by the U.S. FDA in 2021 for eczema in patients that are 12 years old or older. At the time, it was the first topical JAK inhibitor, which blocks inflammation-triggering enzymes, to be approved in the U.S.

Since then, Incyte had inked deals with Chinese and Japanese firms to commercialize the cream in Asian nations. Opzelura was also approved to treat vitiligo in adult patients as well.

The U.S. FDA approval is one of the first gains Incyte has under Meury, who took the helm in June after longtime executive Hervé Hoppenot departed after 11 years at the company.

In a second quarter presentation to investors, Meury said his goals were to build a comprehensive plan for drug acceleration that goes beyond filling the potential revenue shortfall when Jakafi’s exclusivity expires in three years.

He pointed to Opzelura as one of the possibilities to drive future sales, along with chronic graft-versus-host disease treatment Niktimvo and cancer treatment Monjuvi.

“Opzelura is showing strong broad based growth today across AD and vitiligo, has close to 20,000 prescribers and has the potential for new indications in the coming years,” Meury said on the July investor call.

Incyte recorded $1.2 billion at the end of the second quarter, with Opzelura generating $164 million. Jakafi continues to dominate the drugmaker’s portfolio, bringing in $764 million in revenue. Incyte raised its revenue guidance to $3 billion as a result.

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