Dermavant Submits Application to FDA for VTAMA Cream for Atopic Dermatitis Treatment in Adults and Children

Today, Dermavant Sciences announced they’ve submitted a supplemental new drug application (sNDA) to the FDA for VTAMA (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) for adults and children 2-years-old or older.

The biopharmaceutical company developed VTAMA cream as a novel, aryl hydrocarbon receptor agonist in development as a once-daily, 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 United States and is the same strength and formulation studied in the ADORING phase 3 development program and included in the sNDA submission for atopic dermatitis, according to a news release by Dermavant.

AD, also known as a form of 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 United States. More than 85% of people with AD experience itching every day, making it the most common and burdensome symptom, Dermavant said.

In the ADORING trials, VTAMA improved skin conditions, with more patients achieving clear or nearly clear skin compared with those using a placebo. The cream also helped reduce itching, a common symptom of eczema. The trials included patients 12 and older, and the cream demonstrated good safety with mostly mild side effects.

VTAMA was approved in May 2022 for the treatment of plaque psoriasis in adults. In October 2023, Dermavant announced positive results from its phase 4, open-label clinical trial of VTAMA treatment of intertriginous plaque psoriasis (iPsO) in adults. Intertriginous plaque psoriasis inflammatory condition of skin folds

Announced at the 43rd Annual Fall Clinical Dermatology Conference in Las Vegas, the data showed that 82.8% of adult patients saw significant improvement, with clear or almost clear skin, and at least a two-grade enhancement from the start of the trial by Week 12.

The treatment showed rapid efficacy, with success seen as early as 2 weeks and a median time of 6 weeks. By Week 12, 65.5% of patients had completely cleared affected areas.

Additionally, 75% experienced a notable reduction in itch, a common symptom, and reported improved quality of life. The treatment demonstrated safety and tolerability with no new concerns identified during the 12-week trial.