Reaction to tapinarof cream, 1% sNDA submission with Lawrence Eichenfield, MD

Lawrence Eichenfield, MD

On February 14, 2024, Dermavant Sciences submitted a supplemental New Drug Application for tapinarof cream, 1% (VTAMA) to treat atopic dermatitis (AD) in patients 2 years and older.

Click here to read more about the sNDA submission and clinical trial data.

Lawrence Eichenfield, MD, professor of dermatology and pediatrics, vice chair, Department of Dermatology, chief, Pediatric and Adolescent Dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego, California, discussed his reaction to the sNDA submission with Contemporary Pediatrics in the Q+A interview posted below.

Contemporary Pediatrics:

How could a potential FDA approval of tapinarof cream, 1% benefit the child indication for atopic dermatitis?

Lawrence Eichenfield, MD:

AD usually appears in infancy and childhood and is one of the most common inflammatory skin diseases in the [United States], affecting more than 9.6 million children. The disease can result in inflamed, swollen, oozing, 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, affecting more than 85% of affected patients daily. This can affect sleep, which then causes fatigue, leading to other impacts on daily life for children, such as impaired school performance. Beyond the physical discomfort, the visibility of the condition may also lead to adverse psychosocial effects.

Tapinarof, the active ingredient in [tapinarof] cream, 1% is a novel drug demonstrating a proposed new mechanism of action potentially for atopic dermatitis, showing positive safety data, efficacy, and good tolerance in the atopic dermatitis clinical studies from ages 2 years-plus, which complements the data and experience of its use in the topical treatment of plaque psoriasis in adults.

The addition of a highly effective topical, steroid-free medication that decreases inflammation and itch rapidly compared to vehicle, and effectively, could be very helpful in managing AD in children and adolescents.

I am hopeful that if approved by the FDA, it can be useful for both acute treatment and rapid improvement in AD (with data showing decreased itch in some patients within 24 hours of first use) and for long-term management of the signs and symptoms of AD.

Contemporary Pediatrics:

What are the benefits of tapinarof cream, 1% for children 2-years and up related to long-term treatment, given the data recently presented?

Eichenfield:

AD is a burdensome condition, especially for pediatric patients and their caregivers. Having a potential novel, steroid-free topical option for patients with AD, particularly the pediatric population, may provide long-term disease control and symptom reduction capabilities will be very helpful.

The interim analysis of the ADORING 3 open-label, long-term extension study demonstrated that over 50% (373 of 728) of patients using [tapinarof] cream, including both adults and children as young as 2 years old, achieved complete disease clearance (vIGA-ADTM score of 0). While the trial is still ongoing, I am very encouraged by the VTAMA cream AD data.

The efficacy and safety results are consistent with and improve upon the previously reported data from Phase 3 ADORING 1 and 2 pivotal trials, further supporting [tapinarof] cream’s clinical profile and its ability to achieve potential long-term disease control for patients down to age 2 years.

Combined with demonstrating rapid itch reduction in some patients—the most common symptom of AD—these longer-term results underscore the potential of [tapinarof] cream to reshape the current treatment landscape.

Contemporary Pediatrics:

Have you seen any excitement at the pediatrician level regarding tapinarof cream, 1%, with the understanding that it must go through the full FDA approval process?

Eichenfield:

I’ve heard positive responses from my dermatologist and pediatrician colleagues about the Phase 3 [tapinarof] cream AD data, and the potential of having a new, topical, steroid-free treatment option to help with both acute treatment and long-term disease management.

An aryl-hydrocarbon receptor agonist, tapinarof, the active ingredient, seems to have positive impacts on inflammation, skin barrier properties, and itch.

An effective topical agent with minimal systemic effects that may be used in children ages 2 [years] and older, adolescents, and through adulthood may really impact patients suffering from AD!

In a December 2023 video interview with Contemporary Pediatrics, Eichenfield discussed topical steroid and non-steroidal treatments for pediatric AD, and mentioned tapinarof cream 1% as a potential exciting treatment.

Click here to watch the full video interview.