Arcutis Biotherapeutics (ARQT) said Tuesday that the US Food and Drug Administration has accepted its supplemental new drug application for Zoryve foam 0.3% to treat adults and adolescents aged 12 and older with scalp and body psoriasis.
The FDA has set a Prescription Drug User Fee Act target action date of May 22, 2025, the commercial-stage company said.
The sNDA is backed by positive data from Arcutis' pivotal late-stage trial, a phase 2b study, as well as long-term efficacy and safety data generated from the Zoryve cream development program in plaque psoriasis, the company said.
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