The United States Food and Drug Administration has authorized VTAMA for managing atopic dermatitis in adults and pediatrics aged 2 years and above. This decision occurred much earlier than the date that the FDA had set to make their decision by March 12, 2025.
VTAMA cream is a safe topical treatment option that acts as an aryl hydrocarbon receptor agonist, a new mechanism of action for the treatment of skin diseases such as AD. Organon CEO Kevin Ali stated this new approval provides patients with a treatment that carries the prospect of profound skin clearance while lacking any label warnings, restrictions, or precautions on timings of use on body areas. This is a significant step for providing the high unmet medical needs of people suffering from this condition.
VTAMA cream approval follows the success that got after conducting ADORING clinical trials with participation from patients involving 2 years old. VTAMA cream was given to patients who are suffering from modest to severe forms of atopic dermatitis, patients treated with VTAMA demonstrated statistically and significantly more lesional skin with a clear or almost wiped out compared to the placebo group at the end of the study of 8 weeks. In ADORING 1, 45.4% of the patients in the VTAMA group attained greater than or equal to modified IGEF skin clearance compared to 13.9% of placebo-treated patients. Similarly in ADORING 2, the number of patients showing improvement on VTAMA was 46.4% and 18.0% on placebo. This difference was statistically significant in the severity of this disease as measured by the vIGA-AD, an investigator global assessment for atopic dermatitis.
The secondary end points were quite impressive, with a marked decrease in Eczema Area and Severity Index scores and a significant reduction in itching and pruritus, which is the most prevalent and distressing symptom in AD. The peak scores of the pruritus numerical rating scale also showed significant improvement in patients aged 12 years and older.
Additional evidence of VTAMA cream was from the ADORING 3 trial, a 48-week Open Label Trial that was done on 378 patients who completed the previous trials and new patients with AD between the ages of 2-17 with mild to moderate to severe intensity. The research confirmed that the cream removed the skin irritation in many patients and after investigating the patients who managed to clear the skin disease, it was discovered that the patient’s disease-free survival ranges on average from 80 days before the disease reoccurs. As seen in the patients who relapsed, VTAMA cream became effective again upon repeated treatments giving a fast clearance of the skin disease.
The safety assessment of VTAMA cream observed in this long-term study was not significantly different from what was seen in the shorter 8-week trials. It includes common symptoms, like upper respiratory infection, folliculitis, and lower respiratory infection. Most of them were of mild to moderate intensity.
Another significant advantage of this approval is its applicability for children up to 2 years of age. Pediatric approval is particularly noteworthy, as atopic dermatitis can profoundly impact a child’s quality of life, according to Dr. Adelaide A. Hebert. Prolonged itching is especially distressing and challenging both for children as well as for their caregivers. The outcome of the ADORING trial showed that VTAMA cream is useful in the alleviation of pruritus in children.
VTAMA cream was approved by the FDA in May 2022, for plaque psoriasis in adults and has been utilized as a topical non-steroidal medication for psoriasis in the United States for 25 years. Now, with new atopic dermatitis approval, VTAMA cream is ready to develop a more effective strategy to improve the quality of life in more patients. More importantly, this is the first non-steroid topical treatment that will be approved for adult AD patients.
The approval of VTAMA cream for atopic dermatitis treatment offers an opportunity for the treatment of children and adults who have endured severe and painful diseases for years. Showing very encouraging clinical outcomes in trials and with an excellent safety profile, VTAMA cream has major implications for dermatologists as well as patients dealing with atopic dermatitis.
Reference: Organon. FDA Approves VTAMA® (taping of) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. 2024. Accessed from https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/
