FDA approves Arcutis Biotherapeutics’ ZORYVE for pediatric and adult atopic dermatitis

In a significant development for the treatment of atopic dermatitis (AD), Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the U.S. Food and Drug Administration (FDA) approval of ZORYVE (roflumilast) cream, 0.15%, for patients aged six years and older. This approval marks a pivotal advancement in immuno-dermatology, offering a steroid-free, once-daily cream that targets mild to moderate AD with rapid disease clearance and significant itch reduction.

ZORYVE, distinguished by its absence of steroids, emerges as a safer alternative, especially for long-term use, without the risks associated with traditional steroid treatments. Clinical trials underscored its efficacy, with significant improvements noted in symptoms as early as 24 hours after the first application. The treatment was well-received, with over 90% of participants noting some improvement at the four-week mark.

The approval is supported by robust clinical data from three Phase 3 studies, demonstrating ZORYVE’s effectiveness in managing AD symptoms, including pruritus, the most challenging symptom due to skin barrier dysfunction and neuroimmune dysregulation. The results showed a clear advantage over placebos, with 40% of participants achieving almost clear skin after four weeks of treatment.

FDA approves Arcutis Biotherapeutics’ ZORYVE for pediatric and adult atopic dermatitis. Photo courtesy of Arcutis Biotherapeutics, Inc.

Expert opinions highlight the impact of this new treatment. Dr. Lawrence F. Eichenfield from UC San Diego School of Medicine noted the revolutionary aspect of ZORYVE in providing control over AD without the complications of steroids. Similarly, Wendy Smith Begolka from the National Eczema Association emphasized the positive shift in quality of life for both children and adults suffering from AD.

Arcutis is set to make ZORYVE available through key wholesaler and dermatology pharmacy channels by the end of July. They are also committed to ensuring accessibility through patient support programs, aiming to alleviate the financial burden for eligible patients.

The new approval extends beyond ZORYVE cream 0.15% for AD, as the FDA has also approved ZORYVE cream 0.3% for plaque psoriasis and ZORYVE foam 0.3% for seborrheic dermatitis, broadening its impact across dermatological conditions.

As Arcutis continues to innovate in dermatology, the healthcare community watches eagerly, anticipating further developments that could transform the treatment landscape for dermatological diseases.

ZORYVE not only shifts the paradigm in treating eczema by avoiding steroids but also demonstrates significant efficacy and safety in long-term disease management,” stated Dr. Jonathan Silverberg of The George Washington University.