FDA accepts roflumilast's sNDA to treat scalp and body psoriasis in adolescents, adults

FDA accepts roflumilast's sNDA to treat scalp and body psoriasis in adolescents, adults | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

The FDA has accepted a supplemental New Drug Application (sNDA) for roflumilast (Zoryve; Arcutis Biotherapeutics) foam 0.3% to treat individuals aged 12 years and older with scalp and body psoriasis. With this acceptance, the federal agency has assigned a Prescription Drug User Fee Act (PDUFA) date of May 22, 2025.^1,2

Results from the phase 3 ARRECTOR trial, a phase 2b study, and long-term efficacy and safety data from the overall roflumilast cream development program in plaque psoriasis, according to a press release from Arcutis.¹

In the ARRECTOR study—a parallel group, double-blind, vehicle-controlled phase 3 trial—roflumilast foam 0.3% or a matching vehicle were administered once-daily in individuals aged 12 years and older with plaque psoriasis of the scalp and body (n = 432). Results demonstrated that the topical treatment met the primary endpoints, as 66.4% of individuals treated with roflumilast foam 0.3% achieved a Scalp-Investigator Global Assessment (S-IGA) Success. S-IGA success was defined as an IGA score of clear or almost clear, plus a 2-point improvement from baseline, compared to 27.8% of individuals treated with a matching vehicle at week 8 (P < 0.0001).¹

Additionally, 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8 (P < 0.0001).¹

“In clinical studies, investigational once-daily [roflumilast] foam has demonstrated significant improvements in psoriasis signs and symptoms, effectively and reliably improving both scalp and body psoriasis across all efficacy endpoints compared to vehicle,” said Jennifer Soung, MD, director of clinical research, Southern California Dermatology, and clinical trial investigator. "Almost half of individuals with plaque psoriasis experience it on their scalp, accompanied by itchy and sometimes painful plaques, often along with plaques elsewhere on the body. Scalp symptoms can be especially burdensome to manage because hair-bearing areas present unique challenges in terms of treatment application that are not easily addressed with traditional creams or ointments, as they can be inconvenient and messy when used to treat scalp psoriasis."¹

Roflumilast foam 0.3% demonstrated improvement in body itch at week 8, as 63.1% of individuals treated with roflumilast foam 0.3% achieved a 4-or-greater-point reduction in the Worst Itch-Numeric Rating Scale (WI-NRS), compared to those treated with vehicle (30.1% [P < 0.0001]).¹

"“We look forward to working closely with the FDA during the review process," said Frank Watanabe, president, CEO, Arcutis, in a press release. "If approved, [roflumilast foam 0.3%] would represent a truly meaningful innovation for millions of people with scalp and body psoriasis."¹

The most common adverse reactions for roflumilast foam in the phase 3 and phase 2b studies (≥1%) were¹:

• Headache (3.1%)
• Diarrhea (2.5%)
• Nausea (1.7%)
• Nasopharyngitis (1.3%)

If approved, roflumilast foam 0.3% for scalp and body psoriasis treatment would add to the following approved pediatric indications for roflumilast (click each link for more information on each indication)²:

• Roflumilast foam 0.3% to treat seborrheic dermatitis in adult and pediatric patients aged 9 years and older
• Roflumilast cream 0.3% to treat plaque psoriasis in adult and pediatric patients aged 6 years and older
• Roflumilast cream 0.15% to treat mild-to-moderate atopic dermatitis in adult and pediatric patients aged 6 years and older

References:

1. FDA accepts Arcutis' supplemental New Drug Application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents aged 12 and over. Arcutis Biotherapeutics. Press release. September 24, 2024. Accessed September 24, 2024. https://www.arcutis.com/fda-accepts-arcutis-supplemental-new-drug-application-for-zoryve-roflumilast-foam-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/

2. Fitch, J. Roflumilast foam 0.3% sNDA submitted to treat scalp and body psoriasis in patients 12 years and up. Contemporary Pediatrics. July 23, 2024. Accessed September 24, 2024. https://www.contemporarypediatrics.com/view/roflumilast-foam-0-3-snda-submitted-to-treat-scalp-and-body-psoriasis-in-patients-12-years-and-up