Incyte, alongside partner Eli Lilly, is making a heavy push into atopic dermatitis with Olumiant, a JAK inhibitor with a tarnished reputation among regulators. But it never hurts to hedge your bets, and another Incyte med is getting close to its own regulatory filing in the indication.
Incyte's ruxolitinib cream, another formulation of JAK inhibitor Jakafi, topped placebo at significantly or completely clearing skin for atopic dermatitis (AD) patients aged 12 years or older after eight weeks of treatment, according to top-line data released Tuesday.
The phase 3 True-AD2 study enrolled more than 600 patients who'd been diagnosed with AD—otherwise known as eczema—for at least two years and were eligible for topical steroid treatment, the drugmaker said.
Incyte expects to present full study findings at an upcoming medical meeting, and a separate ruxolitinib cream phase 3 study in AD, dubbed True-AD1, is expected later this quarter, the company said in a release.
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But Incyte and Lilly's Olumiant is chasing hard after an AD approval itself. A top-line readout from the Breeze-AD4 study on Monday showed the med topped standard-of-care topical corticosteroids at reducing AD symptoms after 16 weeks in patients whose symptoms had not been controlled by cyclosporine.
Olumiant's expansion into AD is under regulatory review in Europe now, and the drugmakers expect to file in the U.S. and Japan this year. They also plan to present full findings from the Breeze-AD4 study at an upcoming medical meeting.
Originally approved in 2018 as a treatment for rheumatoid arthritis, Olumiant has had a troubled track record on the safety side. The FDA slapped a Black Box warning on the drug's 2-milligram dose for risk of infections, malignancy and thrombosis. And for the higher 4-milligram dose, the FDA knocked Lilly and Incyte in 2018 for unclear safety and efficacy data after an advisory committee voted to turn it down.
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