FDA Approves Organon's Vtama Cream for Atopic Dermatitis in Adults and Children

The US Food and Drug Administration (FDA) has granted approval for Organon's Vtama (tapinarof) cream, 1%, for the treatment of atopic dermatitis in both adults and children as young as two years old. This approval follows closely on the heels of Organon’s acquisition of Dermavant Sciences for approximately $1.2 billion, a strategic move that provided Organon access to this non-steroidal topical therapy.

Atopic dermatitis, commonly known as eczema, is a chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin. It frequently affects areas such as the folds of the arms, the backs of the knees, hands, face, and neck. In the United States alone, over 26 million individuals are impacted by this condition, with global prevalence affecting up to 10% of adults and 20% of children.

Vtama operates as an aryl hydrocarbon receptor agonist and had previously been approved in the US for treating adults with plaque psoriasis. Plaque psoriasis is an immune-mediated disease known for causing inflamed, scaly skin plaques that are often itchy or painful. The FDA's recent decision to expand the use of Vtama to include atopic dermatitis was largely based on robust data from the phase 3 ADORING 1 and ADORING 2 clinical trials.

In these trials, Vtama demonstrated significant efficacy, with 45.4% and 46.4% of patients in ADORING 1 and 2, respectively, achieving clear or almost clear skin. These patients also showed at least a two-grade improvement from baseline to week eight, as assessed by the validated investigator global assessment for atopic dermatitis. In comparison, only 13.9% and 18% of patients in the respective trials who were given a vehicle cream saw similar improvements.

Beyond the primary outcomes, Vtama also showed statistically significant advantages across secondary endpoints. These included enhancements on the Eczema Area and Severity Index (EASI) test, a standard measurement for the extent and severity of eczema, as well as notable reductions in itch. Additionally, data from the long-term extension study, ADORING 3, played a pivotal role in supporting the approval. In this study, a majority of patients either entered with or achieved complete disease clearance at least once during the 48-week open-label period.

Organon's chief executive officer expressed optimism about the implications of the FDA's approval, emphasizing that Vtama represents a potent treatment option for atopic dermatitis. The therapy distinguishes itself by offering significant skin clearance benefits without any label warnings, precautions, or contraindications. Furthermore, there are no restrictions imposed on the duration of use or the percentage of body surface area that can be treated with this cream.

Overall, the introduction of Vtama offers a promising new option for those affected by atopic dermatitis, providing relief from the chronic symptoms of this prevalent skin condition. Its approval underscores Organon’s commitment to addressing unmet needs in dermatological care, enhancing the quality of life for millions of patients dealing with persistent skin disorders.