FDA Approves Expanded Use of Zoryve Cream for Atopic Dermatitis

The FDA has granted approval for Arcutis Biotherapeutics' Zoryve (roflumilast) cream to be used in treating mild to moderate atopic dermatitis in individuals aged six and older. This marks the third indication for Zoryve within two years. CEO Frank Watanabe expressed the company's excitement over the approval, highlighting Zoryve's rapid growth as a widely relied upon steroid-free topical solution, known for its effectiveness and safety.

Arcutis plans to make Zoryve available in its 0.15% strength form through wholesalers and dermatology pharmacies by July 2024. Zoryve functions as a topical PDE4 inhibitor, addressing pro-inflammatory mediators and potentially balancing inflammatory pathways in the skin. Though the exact mechanism remains unclear, it may also directly affect itch-signaling nerves.

Previously, Zoryve had been approved for treating plaque psoriasis in both adults and adolescents aged 12 and older. The new approval for atopic dermatitis opens up a significant market in the U.S., comprising 16.5 million adults and 9.6 million children. Atopic dermatitis is a prevalent form of eczema, characterized by persistent itching and compromised skin barriers.

This regulatory approval was supported by results from three Phase III studies, including INTEGUMENT-1 and INTEGUMENT-2. These trials achieved their primary goal, demonstrating treatment success as indicated by clear or almost clear scores on the Investigator Global Assessment-Atopic Dermatitis scale, coupled with a two-grade improvement at the four-week mark. The INTEGUMENT studies also revealed that Zoryve could considerably alleviate itching and eczema severity, with noticeable effects starting from the first week.

Zoryve was found to be safe, showing low overall rates of treatment-emergent adverse effects, which were mostly mild to moderate. Common side effects included headaches, nausea, and pain at the application site. The approval also leveraged data from a Phase II dose-ranging trial and two Phase I pharmacokinetic studies, apart from the INTEGUMENT program.

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