A supplemental new drug application has been submitted to the FDA for Zoryve cream for the treatment of plaque psoriasis in children aged 2 to 11 years, Arcutis Biotherapeutics announced in a press release.
Zoryve (roflumilast cream 0.3%), a steroid-free, topical phosphodiesterase (PDE4) inhibitor, is approved by the FDA to treat plaque psoriasis in adults and adolescents aged 12 years and older.
“Zoryve is the first topical PDE4 inhibitor approved for the treatment of psoriasis for adults and adolescents,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told