‘Will make life better’: FDA advances Zoryve cream 0.05% for pediatric atopic dermatitis
Key takeaways:
- If approved, this topical will offer a nonsteroidal option for caregivers and their children with atopic dermatitis.
- The FDA has set a target action date of Oct. 13.
The FDA has accepted the supplemental new drug application for Zoryve cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years, according to a press release from the manufacturer.
Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
“A major challenge with AD is that it affects mostly children, but typically new medicines are approved first in adults and then slowly make their way down to younger ages — if we are fortunate,” Peter A. Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine who was not affiliated with the development of Zoryve, told Healio. “Much of my career has been spent using almost everything off label simply because they are not approved in children, yet the children suffer none-the-less. Having nonsteroidal topical options specifically designed for and studied in children is critically important to meeting the needs of pediatric patients.”
The acceptance was supported by three studies: phase 3 INTEGUMENT-PED, extension trial INTEGUMENT-OLE and a phase 1 pharmacokinetic study.
Pivotal phase 3 results
Recently published in Pediatric Dermatology, results from INTEGUMENT-PED showcased the ability of Zoryve cream 0.05% to rapidly reduce itch and clear AD.
Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, vice chair of the department of dermatology at University of California San Diego and lead investigator of the trial, told Healio that this trial reflects a “large amount of work” to try to expand the nonsteroidal options for managing AD in younger patients.
“I am excited to have this particular data on this medication in a population that has a relatively restricted number of approved drugs,” he said.
In the study, 652 children aged 2 to 5 years with an average body surface area involvement of 22% were treated with either Zoryve (n = 437) or vehicle (n = 215) for 4 weeks. After 4 weeks of treatment, 25.4% of the children treated with Zoryve achieved either complete or near complete clearance of their AD, as well as a 2-point improvement of their severity from baseline. On the other hand, only 10.7% of the children treated with placebo saw clearance (P < .0001).
A 75% improvement in disease severity was seen in 39.4% of Zoryve-treated patients compared with 20.6% of vehicle-treated patients (P < .0001). A larger portion of the Zoryve group also experienced a 4-point reduction in their itch severity vs. the vehicle group (35.3% vs. 18%; P = .0002). The researchers observed that itch began to subside within the first 24 hours of applying Zoryve cream 0.05% (P = .0014). The safety profile was tolerable and in line with the favorable findings from adult trials, according to the press release. Treatment-emergent adverse events were low in both groups, with 98.9% being mild or moderate. Also, 0.7% of caregivers or fewer reported their child experiencing stinging, burning or discomfort associated with Zoryve cream 0.05%.
“Parents and caretakers are always going to be really concerned about any potential side effects of a drug,” Eichenfield said. “But this drug was very, very well tolerated with overall really good safety data.”
Next steps
The Prescription Drug User Fee Act target action date for this application is set for Oct. 13, which, according to Lio, cannot come soon enough.
“Topical roflumilast has already become an indispensable part of my toolbox for atopic dermatitis in children and adults,” he said. “Once daily, well tolerated, nonsteroidal, safe for anywhere on the body — it checks all the boxes for what I am looking for to treat AD. Having it for younger patients will make life better for patients, families and clinicians who treat AD, to be sure.”
According to Eichenfield, patients have as much or more concern about potential side effects from topical corticosteroids as ever, making the advancement of nonsteroidal options vital.
“Historically, we’ve relied on topical corticosteroids, especially for cost efficacy. But I think we should be aware of this growing concern which allows us to be more interested and excited in having expanded nonsteroids for eczema,” Eichenfield said.
Editor’s note: On March 5, 2025, the story was updated with quotes from Lawrence F. Eichenfield, MD.