FDA Accepts sNDA for Foam Psoriasis Drug Zoryve

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The FDA has accepted Arcutis Biopharmaceutical Inc.’s supplemental new drug application (sNDA) for Zoryve (roflumilast) 0.3%, a once-daily, topical foam used to treat scalp and body psoriasis, according to a news release published today. The FDA has also set a Prescription Drug User Fee Act (PDUFA) action date for May 22, 2025.

Scalp psoriasis is an extension of body psoriasis, which is characterized by raised, itchy and sometimes painful areas of skin. These areas harden and become covered in a white or silver scale, referred to as plaques. Scalp plaques can also appear on the forehead, behind the ears and on the back of the neck and can lead to hair loss. About half of the 9 million people in the United State with plaque psoriasis have scalp psoriasis as well. Patients with scalp psoriasis often take at least two medications to managed symptoms.

This sNDA approval was based on data from the ARRECTOR phase 3 study, a phase 2b study and safety and efficacy data. In the ARRECTOR study, two-thirds (65.3%) of patients treated with Zoryve achieved clinically meaningful itch reduction by week 8 when compared with 30.3% of vehicle-treated patients. Itch severity was measured using the Scalp Itch-Numeric Rating Scale. Itch reduction was considered clinically meaningful when itch decreased by at least a 4-point change from baseline. Some patients reported itch relief within 24 hours of Zoryve application.

“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,” Jennifer Soung, M.D., director of clinical research at Southern California Dermatology, and clinical trial investigator.

Body psoriasis symptoms also improved when treated with Zoryve. When measured using the Worst Itch-Numeric Rating Scale, itch decreased by 63.1% with Zoryve, when compared to 30.1% of vehicle-treated patients.

The most common adverse reactions were headaches in at least 3.1% of patients, diarrhea (2.5%) and nausea (1.7%).