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2023-12-19| Trials & Approvals

Arcutis Biotherapeutics Receives FDA Approval for Innovative Seborrheic Dermatitis Treatment

by Sinead Huang
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Arcutis Biotherapeutics, Inc. has achieved a significant milestone as the U.S. Food and Drug Administration (FDA) greenlights ZORYVE (roflumilast) topical foam, 0.3%, for treating seborrheic dermatitis in individuals aged 9 years and older. ZORYVE foam, a steroid-free innovation, is a once-daily application for all affected body areas, including those with hair. This marks the first approval in over two decades for seborrheic dermatitis with a novel mechanism of action.

Related article: Dermavant Eyes Second Vtama Indication with Topline Atopic Dermatitis Results

Addressing Unmet Needs

Seborrheic dermatitis is an eczematous skin disorder that affects more than 10 million Americans, and its cause is unknown. The disease usually appears in parts of the body that are rich in sebaceous glands, such as the scalp, side of the nose, eyebrows, eyelids, behind the ears, and in the center of the chest. Sometimes rashes may also appear in the armpits and genitals. The treatment of seborrheic dermatitis faces the challenge of eradicating the lesions and a long course of treatment. ZORYVE Foam demonstrated remarkable efficacy, rapidly clearing lesions from week 2, offering substantial relief from itching within 48 hours. In the STRATUM trial, ZORYVE foam’s effectiveness was evident, with nearly 80% attaining the primary efficacy endpoint of IGA Success, and over 50% achieving complete clearance by Week 8. Dermatology experts laud ZORYVE as a groundbreaking solution, emphasizing its distinctive formula that preserves skin barrier integrity while efficiently diminishing inflammation, redness, and peeling.

In addition to physical symptoms, seborrheic dermatitis can significantly impact quality of life. The approval of ZORYVE brings hope to an estimated 10 million patients by providing an effective, versatile and steroid-free topical formulation. Arcutis plans to put the ZORYVE foam on the market by the end of January 2024, with reasonable price and convenient accessibility as the primary considerations.

Commitment to Accessibility and Patient Support 

Arcutis is committed to ensuring treatment options are available to patients with seborrheic dermatitis and offers two patient support programs, ZORYVE Direct and Arcutis CaresTM, to ensure eligible patients can easily afford treatment and get the support they need. The ZORYVE Direct Program facilitates patient access, assisting in navigating the payer process and reducing out-of-pocket costs for eligible commercially insured patients. The Arcutis Cares patient assistance program (PAP) further extends support, providing ZORYVE at no cost to financially eligible uninsured or underinsured patients.

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