The U.S. Food and Administration has approved tapinarof cream 1% (Vtama, Organon) for treating atopic dermatitis (AD) in adults and children aged two and older.

Tapinarof is a topical aryl hydrocarbon receptor  agonist previously approved by adults with plaque psoriasis.

Tapinarof cream is expected to be available by prescription from a healthcare provider immediately following this approval.

“Following our acquisition of Dermavant, this FDA approval underscores the treatment’s potential to address significant unmet needs in dermatology. By leveraging our expertise and resources, we are committed to supporting its growth and providing patients as young as 2 years old and prescribers with an option that may offer complete disease clearance across the two most common dermatological conditions, with no label safety warnings or precautions, no restrictions on duration of use or percentage of use on affected body surface area,”  says Kevin Ali, Chief Executive Officer of Organon, in a news release.

Experts React

“The approval of tapinarof 1% cream (Vtama) is another big step forward in our shared commitment to drive innovation in topical therapy, the mainstay for atopic dermatitis treatment,” says Raj Chovatiya, MD, PhD, Founder and Director of the Center for Medical Dermatology and Immunology Research in Chicago, IL. “In this case, an aryl hydrocarbon receptor modulator like tapinarof gives us proven safety and efficacy which translates well to a new atopic dermatitis indication, a disease that continues to be in need of advanced topical options that can minimize the chronic use of corticosteroids.”