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Despite JAK ‘anxiety,’ ICER experts overwhelmingly back Incyte’s ruxolitinib cream in atopic dermatitis

July 26, 2021 Fraiser Kansteiner


Officials may have concerns about JAK inhibitor safety overall, but the case for Incyte’s ruxolitinib cream in atopic dermatitis looks good, experts convened by the Institute for Clinical and Economic Review said.

At an evidence review panel late last week, ICER’s panel voted 12 to 1 in favor of ruxolitinib cream’s net benefit, RBC Capital Markets analysts wrote in a note to clients Monday. Topical ruxolitinib, which Incyte sells in oral form as Jakafi, had its FDA decision date pushed back in June after the regulator dialed up its scrutiny on the JAK inhibitor class as a whole. The drug is now up for a decision in atopic dermatitis, also known as eczema, on September 21. 

While JAK inhibitor safety was top of mind for the panel, which looked at a range of atopic dermatitis prospects, the RBC team feels “incrementally more favorable” about topical ruxolitinib’s benefits and launch following the discussion. The analysts cited a perceived “willingness among panelists to use it and among payers to reimburse it.” They expect the drug will win approval late this summer. 

If the drug passes muster at the FDA, ruxolitinib cream’s price tag, duration of treatment and whether or not it comes with a boxed warning will be “critical” to its success, the RBC team added. 

RELATED: Pfizer’s immunology ambitions delayed—again—as JAK drugs fall victim to FDA’s protracted safety review

The analysts figure the drug has 40% chance of debuting with a black box label based on the available data and the FDA’s “historical cautiousness.” Panelists didn’t seem too concerned, pointing to the 15-year-old atopic dermatitis med Protopic, which has a black box warning for “theoretical risks” but hasn’t actually raised any safety signals during its time on the market. 

The class-wide safety saga for JAK drugs kicked off early this year after a postmarketing study linked Pfizer’s popular JAK inhibitor Xeljanz to increased risks of serious heart-related problems and cancer versus TNF inhibitors. Alongside topical ruxolitinib, the FDA has since held up JAK drugs including AbbVie’s Rinvoq, Eli Lilly and Incyte’s Olumiant and Pfizer’s abrocitinib. 

JAK inhibitor “anxiety” and FDA delays were “front and center” among physicians’ concerns, the RBC analysts said. Panelists specifically flagged concerns about the potential for JAK inhibitors to cause non-melanoma skin cancers, which could apply to Incyte’s ruxolitinib cream.

Still, the RBC team voiced confidence that dermatologists could screen for that risk without much trouble. 

RELATED: Arcutis scraps topical JAK phase 2 over drug delivery concerns

Meanwhile, an Incyte representative touted the drug’s safety and noted that the FDA hadn’t flagged issues specific to topical ruxolitinib, suggesting instead that the med had been “swept up in a class concern,” as quoted by the RBC team. The panel conceded that the safety risks posed by ruxolitinib appear to be low but the group “remained deferential” to the FDA’s decision to delay, the analysts said.

While things are looking up for topical ruxolitinib, Incyte has suffered a setback on the oncology front. The company Friday said its investigational PD-1 inhibitor retifanlimab received a complete response letter from the FDA. The drug, which Incyte is studying in locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC), won a priority review tag in January and was originally up for a regulatory decision in July. 

Last month, the FDA’s oncology committee said it needed more data from an ongoing retifanlimab confirmatory trial. The committee had concerns about a lack of trial diversity, deaths linked to the therapy and the drug’s overall efficacy. 



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