Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VTAMA^® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older.

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation studied in the ADORING Phase 3 development program and included in the sNDA submission for atopic dermatitis.

Atopic dermatitis, commonly referred to as eczema, is one of the most common inflammatory skin diseases, impacting approximately 16.5 million adults and more than 9.6 million children in the U.S. Over 85% of people with AD experience itching every day, making it the most common and burdensome symptom. More than 67% of patients with AD report that itch interfered with their sleep in the past week and more than 50% of children with AD report that sleep disturbance is one of the most bothersome symptoms of AD.

“The prevalence of atopic dermatitis, an extremely burdensome skin condition, continues to grow, and there is an increasing need for new, long-term, treatment options, especially for children,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Today’s submission of our sNDA marks a significant milestone as we work towards the approval of VTAMA cream for patients suffering from atopic dermatitis as well as the families and caregivers of these patients. We are confident, that VTAMA cream, if approved by the FDA, will be well positioned as a safe, well-tolerated, steroid-free topical treatment option for patients 2 years of age and older with AD and could provide for long-term disease management, representing meaningful advancement for patients, caregivers, and healthcare providers.”

Today’s sNDA submission is supported by positive Phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as data from an interim analysis of ADORING 3, a Phase 3, 48-week, open-label, long-term extension study. In the pivotal trials, VTAMA cream demonstrated highly statistically significant improvement compared to vehicle (both P<0.0001) in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, the primary endpoint. VTAMA cream also demonstrated highly statistically significant improvement in the proportion of patients with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline to Week 8 compared to patients on vehicle (both P<0.0001), a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population in whom the PP-NRS is validated, who received VTAMA cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another key secondary endpoint. VTAMA cream, 1% data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events.

On May 24, 2022, Dermavant announced the FDA approved VTAMA^® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA cream is a once- daily, cosmetically elegant, steroid-free, topical cream approved for mild, moderate, and severe plaque psoriasis in adults – with no label safety warnings or precautions, or restrictions on duration of use or body surface area.

IMPORTANT SAFETY INFORMATION

Indication: VTAMA^® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

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About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis

ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA^® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study.

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA^® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline