FDA approves the supplemental NDA for Zoryve (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients.- Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc.,  announced the FDA has approved the supplemental New Drug Application (sNDA) for Zoryve (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. Zoryve foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis.

Nearly 9 million people in the United States are living with plaque psoriasis, with over half having scalp involvement and even more presenting with the disease in other hair-bearing areas. These lesions may be difficult to treat with cream or ointments, which can be inconvenient and messy to apply to skin when hair is present. Itch is the most burdensome symptom of psoriasis and can occur anywhere on the body, but occurs more commonly in patients with scalp disease where it is particularly challenging to manage. In clinical trials, Zoryve foam 0.3% demonstrated significant improvements in signs and symptoms of psoriasis on both the body and scalp, with positive results across all efficacy endpoints, and was safe and well tolerated.

“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator. “In clinical trials, Zoryve  foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief. Zoryve can be safely used for any duration and offers two highly convenient formulations, cream or foam, for healthcare providers to choose from. Zoryve foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis.”

“Individuals living with psoriasis, a chronic inflammatory skin disease, want treatments that are not only safe and effective for long-term use but also convenient. With approval for cream and now the foam formulations, individuals and clinicians can choose their preferred administration of Zoryve  with powerful, long-term relief of plaques and itch anywhere on the body, including hair-bearing areas, with no limitation on duration of use,” said Frank Watanabe, president and chief executive officer of Arcutis. “Leveraging our deep medical dermatology expertise, we intentionally formulated Zoryve to meet the needs of individuals with psoriasis, including hard-to-treat areas from head to toe. This is the fifth approval for Zoryve in less than three years and furthers our mission to deliver new treatment options that address the urgent needs of individuals suffering from chronic inflammatory skin diseases.”

Zoryve foam 0.3% is also approved for the treatment of seborrheic dermatitis and is widely availabley via key wholesaler and dermatology pharmacy channels. Arcutis is dedicated to ensuring predictable access for the entire Zoryve portfolio of products, with one simple copay and fulfillment process. The Zoryve  Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed Zoryve  to navigate the payer process, assists patients with adherence, and includes the Zorvye  Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients. Arcutis will also continue to offer the Arcutis Cares patient assistance program (PAP) that provides oryve at no cost for financially eligible patients who are uninsured or underinsured.