Arcutis secures FDA nod for atopic dermatitis cream after delay

Arcutis has achieved its third approval from the US Food and Drug Administration (FDA) for its topical cream, Zoryve (roflumilast), within a span of two years. The latest endorsement targets adults and children with atopic dermatitis, a chronic skin condition marked by dryness, itchiness, and inflammation.

The FDA has sanctioned Zoryve for daily use in treating mild to moderate atopic dermatitis in patients aged six and older. Zoryve, a phosphodiesterase-4 (PDE4) inhibitor, initially gained approval as a cream for plaque psoriasis in July 2022 for patients aged 12 and older. This was followed by an approval in October 2023 for children aged 6-11 with psoriasis.

The decision to expand Zoryve's label for atopic dermatitis was anticipated on June 7, 2024, but experienced a brief delay. However, Arcutis clarified on June 9 that the postponement did not involve additional requests for information from the FDA.

The green light from the FDA is backed by robust data from three Phase III clinical trials, a Phase II dose-ranging study, and two Phase I pharmacokinetic studies. Arcutis unveiled pooled results from the Phase III INTEGUMENT-1 and INTEGUMENT-2 studies in January 2024, showing that 91.5% of patients using Zoryve for atopic dermatitis reported significant improvement in their Eczema Area and Severity Index (EASI) score within four weeks.

For the past five decades, topical steroids have been the primary treatment for atopic dermatitis. However, Zoryve presents a novel alternative that circumvents some of the risks linked with both topical and systemic steroids. According to GlobalData, the atopic dermatitis market is projected to reach $24.4 billion by 2030 across major pharmaceutical markets, including the US, UK, France, Spain, Italy, Germany, and Japan.

Zoryve's label expansion is expected to bolster its sales. The product line, which includes both cream and foam formulations, generated $21.5 million for Arcutis in the first quarter of 2024. GlobalData’s Pharma Intelligence Center forecasts Zoryve to achieve $582 million in sales by 2030.

In the realm of non-steroidal creams, Incyte’s JAK inhibitor Opzelura (ruxolitinib) is a notable competitor, having received approval for atopic dermatitis in 2021. Despite Opzelura's presence, which requires twice-daily application and is approved only for those aged 12 and older, Zoryve might have a competitive edge due to its once-daily application and broader age range.

Arcutis' CEO Frank Watanabe emphasized Zoryve's rapid growth as a steroid-free topical treatment, highlighting its efficacy and safety across various skin locations and durations of use. With the introduction of the new 0.15% strength Zoryve cream for atopic dermatitis, alongside higher-strength cream and foam products, Watanabe expressed confidence in Zoryve's potential to become the leading topical brand in dermatology.