Incyte’s ruxolitinib cream was among a group of JAK inhibitors to have their applications held up at the FDA thanks to a heart safety problem for Pfizer’s Xeljanz. But after surveying doctors, one group of analysts believes the topical atopic dermatitis candidate can be a competitive player.
Most dermatologists will likely still prescribe ruxolitinib cream even if the FDA eventually slaps a class-wide black box warning on the med over potential blood clots and cancer risks, Mizuho analysts said in a Thursday note to clients.
Of 20 doctors the team polled, 75% gave the thumbs-up. Combine that finding with positive feedback from four industry experts in May, the analysts said the drug will likely be a “competitive and market-expansive” topical drug in atopic dermatitis.
The FDA has recently put off a decision for ruxolitinib cream—sold in its pill form as Jakafi for bone marrow disorders—in eczema, as well for other JAK inhibitors in various indications. As SVB Leerink analyst Andrew Berens noted at the time, topical ruxolitinib is viewed as the most important program in Incyte’s pipeline.
The agency appears concerned about a potential class-wide problem for these drugs after a post-marketing study for Pfizer’s Xeljanz found increased risks of cancer and blood clots over TNF inhibitors. The delays raised concerns that a cautious FDA might eventually slap additional warnings on all JAK inhibitors.
But as several surveyed doctors explained in their responses, ruxolitinib cream, a topical agent, doesn’t pose the same systemic risk as the oral drugs do. A class warning won’t likely sway their decisions on using the Incyte med, they said.
No other JAK drugs facing delays at the FDA have so far raised the same level of safety flags as Xeljanz did. These delayed meds include Jakafi, AbbVie’s Rinvoq, Eli Lilly’s Olumiant and Pfizer’s investigational abrocitinib.
Things could get even better for ruxolitinib cream if the FDA roadblock turns out to be a false alarm, the Mizuho team noted. Eighty percent of dermatologists ranked the drug as more efficacious than their go-to topical products, the survey found.
As for potential competition, namely Arcutis’ topical roflumilast and Dermavant’s tapinarof cream, the surveyed doctors said they intend to put more of their patients on the Incyte cream than the other two potential launches if Incyte's offering gets no black box warning.
What’s more, the arrival of other topical treatments might not be bad for ruxolitinib as dermatologists see opportunities for combinations, the Mizuho analysts noted.
As a new agent, ruxolitinib could cost more than existing inexpensive alternatives, including topical calcineurin inhibitors and Pfizer’s Eucrisa. So patient financial support and formulary access will likely be “the most substantial factor in market uptake” for ruxolitinib, the Mizuho team suggested.
The drug is set for a September decision at the FDA after the agency's recent delay.