The US Food and Drug Administration (FDA) has approved Organon’s Vtama (tapinarof) cream, 1% to treat atopic dermatitis in adults and children aged as young as two years.

The approval came less than two months after Organon completed its acquisition of Dermavant Sciences for approximately $1.2bn, giving it access to the non-steroidal topical therapy.

Commonly referred to as eczema, atopic dermatitis is an inflammatory skin disease that results in itchy, red, swollen and cracked skin, often on the folds of the arms, back of the knees, hands, face and neck.

More than 26 million people in the US are affected by the condition, and up to 10% of adults and 20% of children globally.

Vtama is an aryl hydrocarbon receptor agonist that is already approved in the US to treat adults with plaque psoriasis, an immune-mediated disease characterised by inflamed, scaly plaques that may be itchy or painful.

The FDA’s latest decision on the therapy was based on positive results from the identically-designed phase 3 ADORING 1 and ADORING 2 trials, in which 45.4% and 46.4% of patients, respectively, achieved clear or almost clear skin and a minimum two-grade improvement from baseline to week eight on the validated investigator global assessment for atopic dermatitis. This is compared to 13.9% and 18% of those who received vehicle cream in ADORING 1 and 2, respectively.

Statistically significant benefits were seen with Vtama across key secondary endpoints, including improvements on the EASI test, which is used to measure the extent and severity of the condition, and reductions in itch.

Also supporting the approval was data from the long-term extension ADORING 3 study, in which the majority of patients entered with or achieved complete disease clearance at least once in the 48-week open-label period.