Despite FDA holdups, Incyte's still counting on timely Jakafi, ruxolitinib cream verdicts

Jakafi
Incyte has already put in place 120 sales reps in the U.S. for ruxolitinib cream in anticipation of a launch in atopic dermatitis in September, Barry Flannelly, Incyte’s North America chief, said. (Incyte)

Incyte has run into several FDA setbacks in the past few months, including delays for decisions on Jakafi and its topical version ruxolitinib cream. But execs still believe the company can overcome the hiccups, and it’s not waiting to prepare for the rollouts.

After the FDA in June postponed decisions on Jakafi in steroid-refractory chronic graft-versus-host disease (cGVHD) and ruxolitinib cream in atopic dermatitis, Incyte is still confident it can win approvals, CEO Herve Hoppenot said during an investors’ call Tuesday. In fact, the company is already gearing up for the launches.

Following the delays, Incyte now looks to hear back from the agency on rux cream on Sep. 21, and on Jakafi the next day.

Incyte has already put in place 120 sales reps in the U.S. for rux cream, and “they are anticipating the launch in September,” Barry Flannelly, Incyte’s North America chief, said during the call. Moreover, all of the dermatology industry leaders are “fully anticipating the approval of rux cream and looking forward to it,” he added.

The delays for Jakafi and rux cream—as well as many other JAK inhibitors—stemmed from concerning safety findings from a postmarketing study that linked Pfizer’s Xeljanz with increased risks of heart-related side effects and cancer over TNF inhibitors.

RELATED: AbbVie, Lilly atopic dermatitis hopefuls hit with more delays as FDA's JAK inhibitor holdups carry on

In addition to rux cream, AbbVie’s Rinvoq, Eli Lilly’s Incyte-partnered Olumiant and Pfizer’s investigational abrocitinib are also gunning for approvals in atopic dermatitis. Those JAK inhibitors have also have their FDA applications delayed.

While Incyte execs have voiced optimism, there's still reason to question whether the approvals will come in September. The FDA last month further deferred decisions on Rinvoq, Olumiant, Xeljanz and abrocitinib after earlier delays.

As RBC Capital Markets analyst Brian Abrahams sees it, the FDA is likely weighing additional safety analyses from the oral JAK inhibitors to understand safety for topical rux. Longer, 52-week data presented in June from the two phase 3 TRuE-AD trials showed no new safety signals and “no adverse events suggestive of a relationship to systemic exposure,” Incyte’s chief medical officer, Steven Stein, said during the call.

Citing physician enthusiasm for the medicine, Abrahams predicted rux cream could reach $700 million in peak sales in atopic dermatitis.

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

As for Jakafi’s application in cGVHD, Abrahams figured that postponement isn’t likely to have any major impact given the drug is already widely used in the disease off-label. Jakafi is currently approved to treat steroid-refractory acute GVHD.

Meanwhile, Incyte has other expansions planned for its two drugs. Those ambitions could also depend on the outcomes of FDA’s extended review of the JAK class.  

In May, Incyte unveiled that rux cream hit its goals in two phase 3 trials in vitiligo, a skin condition characterized by the loss of pigment cells. The company plans to file in vitiligo “as soon as possible” after the eczema verdict on September 21, Stein said.

For Jakafi, Incyte is advancing a once-daily regimen with a filing now on track for the first half of 2022 pending additional stability data, according to Stein. Jakafi is currently given twice daily.

On the financial side, Incyte said that Jakafi sales grew 12% year-over-year to $529 million in the second quarter. New patient starts for the drug in its three FDA-approved indications—GVHD, polycythemia vera and myelofibrosis—are all back to pre-pandemic levels, Flannelly said.