Arcutis submits supplemental NDA for roflumilast cream for atopic dermatitis

Key takeaways:

• The submission indicates roflumilast 0.15% for adults and children aged 6 years and older with atopic dermatitis.
• The submission is supported by the INTEGUMENT phase 3 trials.

Arcutis Biotherapeutics has submitted a supplemental new drug application to the FDA for roflumilast cream 0.15% for mild to moderate atopic dermatitis treatment in adults and children aged 6 years and older, according to a press release.

Once-daily roflumilast cream is a nonsteroidal topical formulation of a highly potent and selective phosphodiesterase-4 inhibitor. The non-greasy cream, formulated with HydroARQ Technology, is quickly absorbed without disrupting the skin barrier, according to the press release.

“Atopic dermatitis is a chronic and relapsing disease that occurs across the lifespan,” Eric Simpson, MD, MCR, FAAD, professor of dermatology at Oregon Health & Science University in Portland, Oregon, and investigator in the trials that supported this submission, said in the press release. “In clinical studies, once-daily roflumilast cream provided rapid clearance of the disease. In addition, roflumilast cream rapidly reduced itch, one of the most bothersome symptoms to patients, in as little as 24 hours.”

The submission is supported by results from the INTEGUMENT-1 and INTEGUMENT-2 phase 3 trials, both of which met the primary endpoint of IGA success, defined as validated IGA for Atopic Dermatitis scores of 0/1 (clear/almost clear) and a two-grade improvement from baseline by week 4 of the study. This endpoint was achieved by 32% of roflumilast-treated patients in INTEGUMENT-1 and 28.9% of roflumilast-treated patients in INTEGUMENT-2, which compared with 15.2% and 12% of vehicle-treated patients, respectively (P < .0001 for both).

The drug was also well tolerated with treatment-emergent adverse events, most of which were mild to moderate in severity, occurring in no more than 2.9% of patients.