FDA Approves Arcutis' Lower-Strength Dermatitis Cream

Arcutis Biotherapeutics has achieved its third regulatory approval for its PDE4 inhibitor, Zoryve (roflumilast), this week. The FDA has sanctioned a new 0.15%-strength cream formulation to treat atopic dermatitis (AD) in both adults and children aged six and older. This once-daily topical treatment was initially approved as a 0.3% cream in 2022 for treating plaque psoriasis in patients 12 years and older. More recently, a foam version of the same strength received clearance in December to treat seborrheic dermatitis in individuals aged nine and older.

The cream formulation has established itself as a preferred earlier-line option for patients with mild-to-moderate psoriasis, largely due to its better tolerability in comparison to Pfizer’s Eucrisa (crisabarole). Earlier this year, a key opinion leader (KOL) noted that advanced topicals like Zoryve might delay the need for prescribing oral biologics.

The approval of the lower-strength cream was supported by data from two vehicle-controlled Phase III clinical trials, INTEGUMENT-1 and INTEGUMENT-2, which together enrolled 1,337 patients with mild-to-moderate AD. Both trials successfully met their primary endpoint, which required achieving a clear or almost clear skin score and a 2-grade improvement on an investigator global assessment after four weeks of treatment.

In the first trial, about 32% of patients treated with the once-daily cream met the primary endpoint, while in the second trial, 29% of patients achieved this outcome. In contrast, only 15% and 12% of patients in the vehicle arms of the respective trials reached the primary endpoint. Across both studies, around 40% of patients who received Zoryve experienced their symptoms either cleared or almost cleared by the fourth week.

The cream was generally well-tolerated among patients. Common adverse reactions included headache, nausea, application site pain, diarrhea, and vomiting, but these occurred in less than 3% of the patients. Additionally, an application for the 0.15%-strength Zoryve cream is currently under review in Canada.