Sept 18 (Reuters) - The U.S. Food and Drug

Administration has approved Incyte's ( INCY ) eczema cream for

children aged between 2 and 11 years, the company said on

Thursday.

Wilmington, Delaware-based Incyte ( INCY ) 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 ( INCY ) 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.