US-based biopharmaceutical company Arcutis Biotherapeutics has received the US Food and Drug Administration (FDA) approval for Zoryve (roflumilast) cream to treat atopic dermatitis.
Zoryve is a once-daily, steroid-free topical cream that works by inhibiting PDE4, which boosts pro-inflammatory mediators and decreases the production of anti-inflammatory mediators.
The cream provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control.
FDA approved Zoryve cream 0.15% for the treatment of atopic dermatitis in adults and children aged six years and above, and Zorvye cream 0.3% for plaque psoriasis in the same age group.
The product’s other formulation, Zoryve foam 0.3%, is currently available for the treatment of seborrheic dermatitis in adults and children aged nine years and above.
Arcutis has completed its clinical development program for Zoryve foam 0.3% for the treatment of scalp and body psoriasis, with plans to submit to the FDA in the third quarter of this year.
Arcutis president and CEO Frank Watanabe said: “Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.15% as a new steroid-free treatment option to children and adults living with AD.
“With Zoryve, our goal has been to provide a steroid-free topical that can provide effective and fast results, wherever on the body it’s needed, and long-term disease control through a safe and tolerable formulation.
“Zoryve is the fastest-growing steroid-free topical, relied on to provide effective and safe results in any location on the skin for any duration.
“With the addition of the new 0.15% strength of Zoryve cream for AD to the higher-strength cream and foam products, the Zoryve portfolio has the potential to become the preferred topical brand in dermatology.”
Arcutis’ supplementary new drug application (sNDA) is supported by positive results from three Phase 3 studies, a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies.
INTEGUMENT-1 and INTEGUMENT-2 were two identical Phase 3 studies that evaluated the safety and efficacy of Zoryve cream 0.15% in 1,337 participants with mild to moderate AD.
The two Phase 3 studies met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment Atopic Dermatitis (vIGA-AD) score.
In the studies, participants treated with Zoryve cream experienced rapid and significant improvement in itch within 24 hours of the first application.
The Zoryve cream 0.15% was well tolerated in the clinical trials, with the incidence of treatment-emergent adverse events (TEAEs) low in both active treatment and vehicle arms.
The most common adverse reactions in the clinical studies include headache, nausea, application site pain, diarrhoea, and vomiting.
INTEGUMENT study investigator Lawrence Eichenfield said: “The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares.
“Zoryve rapidly improves and controls disease, including itch, the most bothersome reported symptom. In clinical trials, 9 in 10 patients saw some improvement at 4 weeks, with 69% of patients demonstrating a clinically meaningful improvement of at least an EASI-50.
“In addition, Zoryve is a safe and effective steroid-free treatment option. Topical steroids have been the foundation of treatment for AD for the past 50 years.
“Having a new and effective steroid-free option, without some of the risks associated with topical and systemic steroids, is a welcome advancement for dermatologists, patients, and caregivers.”
