FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11 - Seite 2

ZORYVE is the only topical treatment for which efficacy in intertriginous areas (skin folds) was evaluated in the pivotal trials and the only product specifically indicated for use in these areas. A non-greasy, moisturizing cream that absorbs quickly and spreads easily, ZORYVE does not include sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

“Psoriasis is the second most common inflammatory skin disease in children, and it can significantly affect the quality of life of the child, their family members, and caregivers,” said Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation. “We are told by the experts that advise us that there are numerous challenges when it comes to treating children, and finding the right treatment regimen can be difficult, which is why we are encouraged by the advancements being made to alleviate the burden of disease for this population.”

The approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children ages 6 to 11 years with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from this study were generally consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adults. Results from a second MUSE study, in children ages 2 to 5 years, as well as data from an ongoing open label extension study to assess the long-term safety of roflumilast cream 0.3% in individuals with plaque psoriasis 2 years of age and older (ARQ-151-306), will be the subject of a future FDA review.

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About Psoriasis
Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately nine million people in the United States. The majority of individuals with psoriasis develop “plaques,” or raised, red areas of skin covered with a silver or white layer of dead skin cells. The plaques’ clinical presentation may have more grayish, purplish, or brownish tones in people with darker skin tones. Psoriatic plaques are often itchy and sometimes painful and can appear on any area of the body. Plaques in certain anatomical areas present unique treatment challenges, including the face, elbows and knees, scalp, and intertriginous areas (where two skin areas may touch or rub together), such as armpits, under the breasts, groin, and stomach folds.