The FDA approved Opzelura (ruxolitinib) cream yesterday for the treatment of mild to moderate atopic dermatitis (AD) in children as young as two years old, marking the first topical Janus kinase (JAK) inhibitor available for pediatric patients with the chronic skin condition.
Opzelura’s manufacturer, Incyte, announced the expanded approval of the drug for short-term and non-continuous chronic use in non-immunocompromised children ages 2 through 11 whose disease is not completely controlled with other topical therapies or when those therapies are not recommended. The drug was already approved in the U.S. for use in older children and adults with atopic dermatitis as well as in patients 12 and older with nonsegmental vitiligo.
“With this approval, we are now able to offer younger children