FDA approves expanded use for Arcutis’ Zoryve cream

US Immuno-dermatology specialist Arcutis (Nasdaq: ARQT) announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2.

Young children have long faced a treatment gap with few FDA approved options. Zoryve cream 0.3%, a potent and selective PDE4 inhibitor, is the first once-daily, steroid-free therapy approved for children with plaque psoriasis as young as 2 years of age and represents a significant advancement in pediatric psoriasis care.