FDA accepts NDA for ruxolitinib cream to treat atopic dermatitis

A new drug application under priority review for ruxolitinib cream for the treatment of atopic dermatitis has been accepted by the FDA, Incyte announced in a press release.

A selective JAK1/JAK2 inhibitor, ruxolitinib cream showed efficacy in reducing itch and improving quality of life for those with atopic dermatitis in its phase 3 clinical trial program.

“Incyte’s deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch,” Jim Lee, MD, PhD, group vice president, inflammation and autoimmunity, Incyte, said in the release.

The FDA set a Prescription Drug User Fee Act target action date of June 21, which is a 4-month shorter review period because of the priority review voucher.