Arcutis submits sNDA for Zoryve cream 0.05% to treat AD in children aged 2 to 5 years

Key takeaways:

• Zoryve cream 0.05% is a nonsteroidal, phosphodiesterase 4 inhibitor that has shown efficacy in clinical trials.
• The application was supported by three studies, including the phase 3 INTEGUMENT-PED trial.

Arcutis Biotherapeutics has submitted a supplemental new drug application to the FDA for Zoryve cream 0.05% for the treatment of pediatric mild to moderate atopic dermatitis, according to a press release.

The application of Zoryve (roflumilast) cream 0.05%, a once-daily, steroid-free, phosphodiesterase 4 inhibitor, is indicated for children who are aged 2 to 5 years — a population whose caretakers especially look for nonsteroidal options to manage their AD.

“The vast majority of children with eczema are topically treated today. Providers and caregivers of these young children face unique considerations when choosing a therapy, such as the sensitive skin of pediatric patients and planning treatments for long-term use,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “For the approximately 1.8 million children between the ages of 2 to 5 who are topically treated for AD, Zoryve cream 0.05% has the potential to advance the standard of care.”

The sNDA is backed by data from a phase 3 trial, a long-term extension study and a phase 1 pharmacokinetic trial.

The phase 3 trial, INTEGUMENT-PED, which included 652 children aged 2 to 5 years with AD, showed that 25.4% of those children treated with Zoryve achieved validated IGA-AD 0 or 1 as well as a 2-grade improvement from baseline, whereas only 10.7% of the vehicle group achieved the same (P < .0001).

Of the children in the Zoryve group that reported a Worst Itch Numeric Scale score of 4 or higher, 35.3% were able to reach a 4-point reduction vs. 18% of the vehicle group (nominal P = .0002).

The safety profile of Zoryve in this population remained consistent and favorable in the trial with the most common adverse events occurring more frequently in the treatment arm being upper respiratory tract infections, diarrhea and vomiting.

“Zoryve cream 0.05% has a well-established efficacy, safety and tolerability profile from our clinical trials and was formulated to deliver the drug without disrupting the skin barrier or using sensitizing excipients and irritants,” Burnett told Healio. “If approved, the lower-dose concentration of Zoryve cream 0.05% would provide an important new treatment option for young children, providing an effective and well-tolerated steroid-free option.”