FDA Approves Arcutis’ Zoryve for Plaque Psoriasis

The FDA has approved Arcutis Biotherapeutics’ Zoryve (roflumilast) cream 0.3 percent for treatment of patients 12 years and older with plaque psoriasis and in intertriginous psoriasis — a type of psoriasis associated with inflammatory lesions in skin folds.

The approval makes Zoryve the only topical phosphodiesterase-4 (PDE4) inhibitor approved for treating plaque psoriasis. PDE4 inhibitors reduce inflammation by blocking PDE4 enzyme activity.

In two phase 3 studies, the drug showed meaningful improvements in clearer skin and in reducing the severity and impact of itching.

The company plans to launch the once-daily nonsteroidal drug by mid-August.