Current Edition

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. 

The delay for ruxolitinib cream shouldn’t come as a complete surprise. Earlier this year, the FDA said a postmarketing study on Pfizer’s popular JAK inhibitor Xeljanz found increased risks of serious heart-related problems and cancer compared with TNF inhibitors. 

Since then, the agency has held up a host of JAK inhibitors seeking new uses and initial approvals, including AbbVie’s new Rinvoq, Eli Lilly’s Incyte-partnered Olumiant and Pfizer’s investigational abrocitinib. The FDA also delayed Xeljanz’s decision date in ankylosing spondylitis. 

For Incyte, the delay comes after its ruxolitinib cream posted back-to-back phase 3 trial wins in atopic dermatitis early last year. Aside from atopic dermatitis, the company plans to seek approvals for ruxolitinib cream in vitiligo after positive results in late-stage studies last month. Incyte and partner Eli Lilly are also gunning for an FDA approval for oral JAK drug Olumiant in atopic dermatitis.

Meanwhile, the ruxolitinib cream delay could give another topical competitor, Leo Pharma’s delgocitinib cream, a chance to play catch up. That drug scored an FDA fast track designation last August and started phase 3 testing in chronic hand eczema last month.

As a host of JAK drugs eye the atopic dermatitis market, the eczema king—Sanofi and Regeneron’s Dupixent—continues to reign. The IL-4 and IL-13 inhibitor pulled in more than €1 billion during the first quarter and is on its way to delivering €10 billion in peak sales, Sanofi execs say. 

Still, there’s plenty of room for growth in the AD market—at least according to AbbVie’s president Michael Severino. Speaking at a recent Bernstein investor conference, he said AbbVie expects the $4 billion AD market to triple in the next few years. AbbVie expects an FDA decision for its Rinvoq in atopic dermatitis this summer.