PracticalDermatology

FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Patients 9 Years and Older

Arcutis Biotherapeutics, Inc. announced the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in those 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades, Arcutis said in a press release.

“Seborrheic dermatitis is a common yet poorly understood chronic dermatosis associated with redness, flaking, and itch in characteristic areas of the body, including the head and neck,” Raj Chovatiya, MD, PhD, explained in an interview with Practical Dermatology®. Recent studies have suggested that the burden of this disease is much higher than previously appreciated, with many patients waiting years for appropriate diagnosis and not achieving longitudinal control with conventional, unapproved, non-targeted therapy (namely, topical corticosteroids), resulting in immense polypharmacy, he continued. Dr. Chovatiya is assistant professor of dermatology at the Northwestern University Feinberg School of Medicine in Chicago, IL.

The debate about primary pathogenic drivers in this condition, along with difficulty in efficiently delivering a drug to hair-bearing areas, have been two important reasons why drug development has been slow in this space, according to Dr. Chovatiya.

“The approval of roflumilast 0.3% foam is a major step forward in treatment of this disease,” he said. “As a phosphodiesterase-4 inhibitor in a water-based foam vehicle, we now have a treatment that targets a key enzyme in the inflammatory cascade (suggesting the primary importance of immune dysregulation in this disease) that can easily be delivered to the areas of the skin that need it most.”

In addition, based on the phase 3 clinical trials in which roflumilast was studied, he noted, a majority of patients achieved complete skin clearance in weeks and had meaningful improvement in itch.

“It’s exciting to see how this treatment will not only change our primary approach to seborrheic dermatitis, but also promote further investigation into this disease and development of novel therapeutics,” he concluded.

FDA Approval of (tralokinumab-ldrm) for Moderate-to-Severe Atopic Dermatitis in Pediatric Patients Aged 12-17 Years

The US Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, LEO Pharma Inc. announced. Adbry is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of AD signs and symptoms.^1,2,3

• More than five times as many pediatric patients had clear or almost clear skin with Adbry compared to placebo: 21% of patients who received Adbry achieved an Investigator’s Global Assessment (IGA) score of 0 (“clear”) or 1 (“almost clear”) compared to 4% who received placebo.¹
• Approximately five times as many pediatric patients saw a substantial disease improvement with Adbry compared to placebo: 29% of patients who received Adbry achieved at least a 75% improvement in their Eczema Area and Severity Index score (EASI-75) compared to 6% who received placebo.¹
• More than seven times as many pediatric patients experienced significantly reduced itch with Adbry compared to placebo: 23% of patients who received Adbry achieved at least a four-point reduction in Adolescent Worst Pruritis Numerical Rating Scale (NRS) compared to 3% with placebo.¹
• In ECZTRA-6, a higher proportion of pediatric patients who received Adbry achieved at least a 90% improvement in their Eczema Area and Severity Index score (EASI-90) compared to placebo.¹

An initial loading dose of 300 mg, followed by a 150 mg dose every two weeks is approved for US pediatric patients aged 12 to 17 years.¹

The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adbry in 289 pediatric patients aged 12 to 17 years with moderate-to-severe AD who were candidates for systemic therapy. A total of 98 patients received an initial dose of Adbry 300 mg followed by 150 mg every other week up to Week 16. The trial met its primary and key secondary endpoints¹:

• More than five times as many pediatric patients had clear or almost clear skin with Adbry compared to placebo: 21% of patients who received Adbry achieved an Investigator’s Global Assessment (IGA) score of 0 (“clear”) or 1 (“almost clear”) compared to 4% who received placebo.¹
• Approximately five times as many pediatric patients saw a substantial disease improvement with Adbry compared to placebo: 29% of patients who received Adbry achieved at least a 75% improvement in their Eczema Area and Severity Index score (EASI-75) compared to 6% who received placebo.¹
• More than seven times as many pediatric patients experienced significantly reduced itch with Adbry compared to placebo: 23% of patients who received Adbry achieved at least a four-point reduction in Adolescent Worst Pruritis Numerical Rating Scale (NRS) compared to 3% with placebo.¹
• In ECZTRA-6, a higher proportion of pediatric patients who received Adbry achieved at least a 90% improvement in their Eczema Area and Severity Index score (EASI-90) compared to placebo.¹

The safety of Adbry, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to the safety profile from trials in adults with atopic dermatitis. In the ECZTRA 1, 2, and ECZTRA 3 adult trials, the most common adverse events (incidence ≥1%) were upper respiratory tract infections (mainly reported as the common cold), conjunctivitis, injection site reactions, and eosinophilia.¹

“We know the symptoms associated with moderate-to-severe atopic dermatitis can have an impact on pediatric patients, which is why it’s so important to have treatment options with demonstrated efficacy in itch reduction and skin clearance,” said Amy Paller, MD, Chair, Department of Dermatology, Feinberg School of Medicine, Northwestern University in Chicago, the international coordinating investigator for ECZTRA 6. “Clinical trial results that provide this evidence are invaluable to clinicians evaluating the safety and efficacy of treatment options for their pediatric patients.”

Dr. Paller is an ECZTRA 6 clinical trial investigator and a paid consultant of LEO Pharma Inc.

1. Adbry® (tralokinumab-ldrm) Prescribing Information. LEO Pharma; December 2023.

2. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

3. Popovic B, et al. Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219.