Arcutis Biotherapeutics Submits Supplemental New Drug Application for Roflumilast Cream for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age

Biopharmaceutical company, Arcutis Biotherapeutics, has submitted a Supplemental New Drug Application (SNDA) to the U.S. Food and Drug Administration (FDA) for the expanded indication of Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children aged 2 to 11 years.

In July 2022, the FDA approved the use of Zoryve for the topical treatment of plaque psoriasis in adults and children aged 12 years and above. As a nonsteroid, phosphodiesterase-4 (PDE4) inhibitor, Zoryve was shown to effectively clear plaque psoriasis in hard-to-treat areas like the knees and elbows, and sensitive areas such as the face, intertriginous areas, and genitalia.

This recent SNDA submission is based on data from two four-week Maximal Usage Systemic Exposure (MUSE) studies (NCT04655313; NCT04746911) conducted in pediatric patients aged 2 to 11 years with plaque psoriasis. Data from these two studies are consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials of the July 2022 approval.

“Zoryve demonstrated a favorable safety and tolerability profile in this pediatric population, with minimal local site reactions.” – Frank Watanabe, President and CEO at Arcutis.

If approved, Zoryve will be the first steroid-free topical (PDE4) inhibitor for pediatric patients with plaque psoriasis.

Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, stated, “Zoryve is the first PDE4 approved for the treatment of psoriasis and, if approved by the FDA with the new data, dermatology clinicians will be able to treat patients down to 2 years of age.”




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