- Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp
- Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial
- Data also show rapid reduction in scalp itch as soon as 24 hours after first application
- ZORYVE 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 Watanabe, president and chief executive officer of Arcutis. “Our team’s ability to execute our clinical development and commercial strategies reinforces Arcutis’ leadership in medical dermatology and positions the ZORYVE portfolio as a new standard of care for the effective treatment of multiple immune-mediated, chronic skin diseases. I would like to thank the clinical investigators, study coordinators, patients, and caregivers who participated in our clinical trials.”
About the DataThe submission is supported by positive results from Arcutis’ pivotal ARRECTOR Phase 3 trial, a Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis.
The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study was a parallel group, double-blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in individuals with plaque psoriasis of the scalp and body ages 12 and older (n=432). The study met its co-primary endpoints with 67.3% of individuals treated with roflumilast foam achieving Scalp-Investigator Global Assessment (S-IGA) Success (IGA Success is defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline) compared to 28.1% of individuals treated with a matching vehicle foam at Week 8 (P