Arcutis Biotherapeutics, Inc’s Zoryve Gets FDA Approval for Seborrheic Dermatitis

The FDA has approved Arcutis Biotherapeutics, Inc’s Zoryve (roflumilast) topical foam, 0.3% to treat seborrheic dermatitis in patients aged 9 years and older. The once-daily, steroid-free foam is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades, according to Arcutis Biotherapeutics.¹

Zoryve (roflumilast) topical foam, 0.3%. Credit: Arcutis Biotherapeutics.

“We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a press release. “Zoryve foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of Zoryve foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.”¹

Zoryve is a highly potent and selective phosphodiesterase type 4 inhibitor in development to treat inflammatory dermatoses, particularly areas with hair, such as the scalp. In the pivotal Phase II Trial 203 and Phase III STRATUM trials, Zoryve was found to provide rapid disease clearance and a significant improvement in itch. The parallel group, double-blind, vehicle-controlled trials analyzed the safety and efficacy of Zoryve treating seborrheic dermatitis among 683 adult and adolescent patients aged 9 years and older.

The STRATUM trial achieved its primary endpoint with 79.5% of patients administered Zoryve reached the Investigator Global Assessment (IGA) Success rate at week eight compared with 58.0% of vehicle patients. In Trial 203, 73.1% of individuals administered Zoryve achieved IGA Success compared with 40.8% vehicle.

Zoryve was found to produce a statistically significant improvement in IGA Success at week two compared to vehicle. Further, 50.6% of patients administered Zoryve achieved complete clearance at week eight. Patients administered Zoryve also achieved a statistically significant improvement compared with vehicle across all secondary endpoints, including itch, scaling, and erythema.

Further, 62.8% of patients administered Zoryve achieved a ≥4-point reduction in itch at week eight as measured by Worst Itch-Numerical Rating Score compared with 40.6% of the vehicle group. There were also significant improvements in itch observed at weeks two and four. Patients in the Zoryve group achieved a 28% improvement in itch from baseline in 48 hours vs. 13% in the vehicle group.

The drug was generally well tolerated, with the incidence of treatment-emergent adverse events (TEAEs) being low and similar between the active treatment and vehicle cohorts. Most of the observed TEAEs were mild to moderate in severity, with no serious TEAEs reported.

Overall, the most common AEs were COVID-19, nasopharyngitis, nausea, and urinary tract infection. The study showed that more than 90% of patients randomly assigned to use Zoryve completed the full 8 weeks and 0.7% in the Zoryve arm and 2% in the vehicle arm discontinued the study because of AEs.²

“In the STRATUM trial, Zoryve foam provided rapid disease clearance as early as Week 2 and significant itch relief in as little as 48 hours. In addition, almost 80% of patients achieved treatment success at week 8,” STRATUM trial investigator Andrew Blauvelt, MD, MBA, clinical investigator at Oregon Medical Research Center, said in a press release. “While multiple factors contribute to seborrheic dermatitis, inflammation and skin barrier dysfunction play key roles. Zoryve has been shown to effectively reduce the signs of inflammation, redness, and scaling in patients with seborrheic dermatitis, and with its unique formulation, Zoryve foam effectively delivers the drug without disrupting the skin barrier and has been shown to be safe and tolerable. Zoryve foam is thus ideally formulated, having the potential to become the new standard of care for seborrheic dermatitis treatment.”¹

In a press release, Arcutis said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

“Approximately 10 million people in the United States have seborrheic dermatitis, but until today, there have been limited treatment options. We are thrilled with this FDA approval and are excited to bring to market a new, highly effective steroid-free topical formulation that can be used anywhere on the body,” said Frank Watanabe, president and CEO of Arcutis. “Our commercial team is ready and poised to launch Zoryve foam very soon, and we are committed to ensuring affordable access to Zoryve foam to those who may benefit from this novel treatment.”¹

References

1. FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older. Arcutis Biotherapeutics, Inc. News release. December 15, 2023. Accessed December 18, 2023. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/

2. Arcutis announces positive topline results from STRATUM pivotal phase 3 trial of roflumilast foam 0.3% in seborrheic dermatitis. Arcutis Biotherapeutics. News release. June 6, 2022. Accessed December 18, 2023. Email.