Arcutis Receives FDA Approval For Its SNDA ZORYVE

(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT) on Friday announced that the FDA has given its approval for the company's supplemental new drug application (sNDA) to extend the usage of ZORYVE (roflumilast) cream 0.3% to children between the ages of 6 and 11 for the treatment of plaque psoriasis, including intertriginous areas.

The approval was based on data from a 4-week study, Maximal Usage Systemic Exposure (MUSE), in children aged 6 to 11 with plaque psoriasis. The study showed that the safety, tolerability, efficacy, and pharmacokinetic data were consistent with data from Phase 3 trials in adults (DERMIS-1 and DERMIS-2).

ZORYVE is a non-greasy, moisturizing cream that is quickly absorbed, spreads easily, and does not contain irritants or sensitizing excipients.

Furthermore, the company stated that the FDA will review results from a second MUSE study in children aged 2 to 5 years and data from an ongoing open-label extension study (ARQ-151-306) assessing the long-term safety of roflumilast cream 0.3% in individuals with plaque psoriasis who are 2 years of age and older in the future.