Arcutis submits supplemental NDA for Zoryve to treat plaque psoriasis in children

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 Healio. “If approved by the FDA with this new data, dermatology clinicians will be able to treat patients down to 2 years of age.”

The submission is based on pharmacokinetic, safety, tolerability and efficacy data from two MUSE studies, which are consistent with previously published data from the DERMIS-1 and DERMIS-2 phase 3 trials.

“Safety and tolerability are critically important in the treatment of children, and today young children lack topical treatment options for plaque psoriasis,” Burnett said in the press release. “This submission is an exciting step in Arcutis’ efforts to expand the availability of an effective, steroid-free treatment for children with plaque psoriasis.