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Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpOnce-daily ZORYVE foam
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpOnce-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trialData also show rapid reduction in scalp itch as soon as 24 hours after first applicationZORYVE foam demonstrated a favorable safety and tolerability profile WESTLAKE VILLAGE, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. “Nearly half of all individuals with plaque psoriasis have involvement of the scalp. Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and clinical trial investigator. “Clinical data show that investigational once-daily ZORYVE foam effectively and reliably cleared both scalp and body psoriasis across all efficacy endpoints compared to vehicle, including 67% of participants achieving Scalp-Investigator Global Assessment Success with ZORYVE foam at 8 weeks. These data demonstrate that ZORYVE foam, if approved, would be an important new treatment option for those living with psoriasis.” \"This important milestone represents our fifth topical roflumilast regulatory submission in the United States in less than three years and brings another innovative treatment to the large population of individuals with scalp and body psoriasis. Based on the rapid adoption of ZORYVE foam in seborrheic dermatitis due to the simplicity of using one treatment anywhere on the body, including hair-bearing areas, we believe there is great potential for its adoption in scalp and body psoriasis, once approved,” said Frank Watana...