The ADORING 3 phase 3 development program is currently studying the novel, aryl hydrocarbon receptor agonist as a once-daily, cosmetically elegant, and steroid-free topical cream for adults and children with atopic dermatitis.
The FDA has accepted a supplemental new drug application (sNDA) for tapinarof (Vtama) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older, Dermavant Sciences announced today in a release.1
The FDA has accepted an sNDA for tapinarof cream 1% for treatment of atopic dermatitis / Araki Illustrations - stock.adobe.com
A previous FDA approval of tapinarof for the treatment of plaque psoriasis in adults made the cream the first non-steroidal topical novel chemical entity launched in the psoriasis market in the US in over 2 decades. The ADORING 3 (NCT05142774) phase 3 development program is currently studying the same strength and formulation of the novel, aryl hydrocarbon receptor agonist as a once-daily, cosmetically elegant, and steroid-free topical cream for both the acute treatment and long-term management of AD.
Trial Name: Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
Clinicaltrials.gov Identifier: NCT05014568
Sponsor: Dermavant Sciences GmbH
Summary: This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.
The application was supported by positive phase 3 data from ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859)—2 identical, double-blind, randomized, vehicle-controlled, pivotal trials—as well as interim analysis results of ADORING 3.
“The FDA acceptance of our sNDA is an important milestone in our efforts to bring tapinarof cream, as a potentially safe and well-tolerated non-steroidal treatment option, to adults and children as young as 2 years old who suffer from AD,” said Todd Zavodnick, chief executive officer of Dermavant in a release.1 “Our commitment to patients is unwavering, and we remain highly focused on preparing for the commercial launch of tapinarof cream, subject to FDA approval, for its second indication of AD.”
Positive topline results from ADORING 2 released in March 2023 revealed that among 406 patients, 46.4% receiving tapinarof achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis—a standardized severity assessment for the condition—response of clear or almost clear with an at least 2-grade improvement from baseline at week 8 compared to 18% on vehicle.2 Adverse events included contact dermatitis and follicular events but were mild to moderate.
READ MORE: Efficacy of Tapinarof Cream 1% Demonstrated in Atopic Dermatitis in Skin of Color
Results from ADORING 1, released later in May 2023, met the primary and all key secondary endpoints consistent with results from the ADORING 2 trial. In ADORING 1, a significant improvement in itch was observed in participants 12 years and older that used tapinarof. Among this cohort, 61.1% achieved a reduction of 4 points or more in the Pruritus Numeric Rating Scale—a patient-reported outcome of itch severity—at week 8 (P = .0366).3
AD, also known as eczema, is one of the most common inflammatory skin conditions that causes intense itching, redness, and irritation. It affects millions of children and adults in the US and can exact a significant burden on patients with the condition. Constant itch is among the most burdensome symptom of AD, contributing to anxiety, depression and social isolation associated with distress due to the visibility and discomfort of the condition, as well as sleep disruption which can lead to inattention in school among children. Results from ADORING 1 and ADORING 2, however, hold promise for providing relief to patients as young as 2 years old.
“AD affects a significant number of children, and its prevalence continues to grow,” said Adelaid A. Hebert, MD, professor and chief of pediatric dermatology, McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann in a release from Dermavant.3 “The prevalence of itch as an associated symptom makes this condition extremely burdensome not only to the patients suffering from AD, but also to their families. In this regard, the itch data from ADORING 1, much like that from ADORING 2, emphasizes [tapinarof’s] effectiveness when it comes to disease control and [tapinarof’s] potential to reduce one of AD’s most burdensome symptoms.”
The FDA has assigned a PDUFA date in quarter 4 of 2024 for the company’s sNDA application.
READ MORE: Dermatology Resource Center
