Incyte hits 2nd FDA delay in span of days, this time for atopic dermatitis hopeful ruxolitinib cream

Despite back-to-back phase 3 trial wins in atopic dermatitis, Incyte’s ruxolitinib cream isn’t immune to class-wide JAK inhibitor safety scrutiny.

Incyte on Friday disclosed that the FDA has put off its decision for ruxolitinib cream in atopic dermatitis by three months, making the drug's new decision date September 21. The move comes just days after the agency pushed back its decision on the oral version of ruxolitinib—Jakafi—in chronic graft-versus-host disease.