sNDA Accepted for Roflumilast Foam 0.3% for Psoriasis

The US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for roflumilast foam 0.3%—a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor branded ZORYVE by Arcutis Biotherapeutics, Inc.—for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.

The FDA assigned the application a PDUFA target action date of May 22, 2025, Arcutis said in a press release.

“In clinical studies, investigational once-daily ZORYVE 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 at 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. The unique formulation of ZORYVE foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis.”

Frank Watanabe, president and chief executive officer of Arcutis, said an approval would represent a “truly meaningful innovation for millions of people with scalp and body psoriasis whose symptoms have not been adequately addressed by existing treatments.”

“We look forward to working closely with the FDA during the review process for our fifth topical roflumilast regulatory submission in the United States in less than 3 years,” Watanabe said. “This filing acceptance is a critical milestone in our mission to deliver new treatment options that address the urgent needs of individuals living with immune-mediated diseases and conditions.”

The sNDA 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.