FDA accepts supplemental application for Zoryve foam for scalp, body psoriasis
Click Here to Manage Email Alerts
Key takeaways:
- The FDA accepted the supplemental new drug application for Zoryve foam 0.3% to treat adults and adolescents with scalp and body psoriasis.
- The Prescription Drug User Fee Act date is set for May 22, 2025.
The FDA has accepted Arcutis Biotherapeutics’ supplemental new drug application for Zoryve foam 0.3% for the treatment of scalp and body psoriasis in adults and adolescents aged 12 years and older, the company announced in a press release.
Zoryve (roflumilast) foam 0.3% in this indication has received a Prescription Drug User Fee Act date of May 22, 2025.
“Zoryve foam, if approved, 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,” Frank Watanabe, president and CEO of Arcutis, said in the release. “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.”
The submission was supported by results from the phase 3 ARRECTOR trial as well as a phase 2b study and long-term data from a study evaluating Zoryve cream in plaque psoriasis.
In the ARRECTOR study, 432 patients aged 12 years or older received Zoryve foam 0.3% or vehicle once daily for scalp and body plaque psoriasis.
At week 8, results showed that 66.4% of individuals treated with Zoryve foam vs. 27.8% of those treated with vehicle achieved an IGA score of clear or almost clear plus a 2-point improvement from baseline for the scalp (P < .0001). Similar results were seen for the body (45.5% vs. 20.1%; P < .0001).
A 4-point or more improvement from baseline to week 8 on the Worst Itch-Numeric Rating Scale was also observed in 63.1% of Zoryve-treated patients vs. 30.1% of vehicle-treated patients (P < .0001).
Adverse events were also low with the majority being mild to moderate in severity.