Arcutis Biotherapeutics gets ZORYVE FDA approval for seborrheic dermatitis

Arcutis Biotherapeutics, Inc., a pioneer in immuno-dermatology, has announced the U.S. Food and Drug Administration’s (FDA) approval of their new drug application for ZORYVE (roflumilast) topical foam, 0.3%, aimed at treating seborrheic dermatitis in individuals aged 9 years and older. This approval marks a significant advancement in dermatological care, with ZORYVE being the first drug with a new mechanism of action for this condition in over twenty years.

Breakthrough in Seborrheic Dermatitis Treatment

ZORYVE foam is recognized for providing rapid disease clearance and a significant reduction in itch, a primary symptom of seborrheic dermatitis. In the STRATUM trial, nearly 80% of participants achieved primary efficacy, with over 50% reaching complete clearance by Week 8. This steroid-free, once-daily treatment can be used on all body areas, including hair-bearing regions, without usage duration limitations.

The Impact of ZORYVE on Seborrheic Dermatitis

Seborrheic dermatitis, affecting over 10 million people in the U.S., is a chronic skin disease characterized by red patches and persistent itch. The condition is particularly challenging to manage due to the difficulty in treating hair-bearing areas. ZORYVE foam’s unique formulation allows for effective application in these areas, making it a potential game-changer in dermatological care.

Clinical Trials and Safety Profile

Clinical trials, including the STRATUM trial, have demonstrated ZORYVE foam’s ability to provide rapid relief from disease symptoms and significant itch reduction. Andrew Blauvelt, a clinical investigator, emphasized ZORYVE’s effectiveness in reducing inflammation, redness, and scaling, deeming it a potential new standard for seborrheic dermatitis treatment.

Arcutis’ Commitment to Accessibility and Future Plans

Arcutis is dedicated to ensuring affordable access to ZORYVE foam. Frank Watanabe, president and CEO of Arcutis, expressed excitement about bringing this new treatment to market. The company plans to make ZORYVE foam available through key wholesalers and dermatology pharmacy channels by the end of January 2024.