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FDA approves Arcutis’ Zoryve for the treatment of atopic dermatitis

Adults and children 6 years or older are approved to use the cream.

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company focused on developing innovations in immuno-dermatology, announced the U.S. Food and Drug Administration has approved the supplemental new drug application for Zoryve (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and pediatric patients 6 years of age and older. Zoryve is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and is designed to be a treatment option for long-term disease control.

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“Due to the chronic and relapsing nature of atopic dermatitis, those living with the disease often feel as though they are constantly chasing their flares and treating reactively,” said Lawrence F. Eichenfield, M.D., professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, and INTEGUMENT study investigator. “Zoryve rapidly clears and controls disease, including itch, with 9 in 10 patients experiencing symptom improvement at 4 weeks as measured by EASI. In addition, Zoryve is a safe and effective, steroid-free treatment option, that can be used long term.”

"Living with atopic dermatitis and the intense itching associated with it, as well as the chronic and relapsing nature of the condition, can have a profound impact on quality of life for the individual and their families and caregivers," said Wendy Smith Begolka, chief strategy officer, at the National Eczema Association. “We are pleased to see new advancements and innovation in treatment for the millions of people who are suffering with this serious skin disease.”

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Arcutis intends to make Zoryve cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July. The company said it is dedicated to ensuring predictable access for the 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 Zoryve 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 CaresTM patient assistance program (PAP) that provides Zoryve at no cost for financially eligible patients who are uninsured or underinsured.

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