Organon has announced the recent approval of Vtama ® (tapinarof) cream 1% for atopic dermatitis (AD) in adults and children aged 2 years and older.
Vtama, an aryl hydrocarbon receptor agonist, was approved in May 2022 for the treatment of plaque psoriasis in adults. Approved for mild, moderate, and severe plaque psoriasis, it became the first non-steroidal topical novel chemical entity for plaque psoriasis in the U.S. in more than 25 years.
This recent approval for AD for patients 2 years and above comes after positive results from the phase 3 ADORING trials. Adults and pediatric patients aged two years and above with moderate-to-severe AD were randomly assigned to receive either once-daily Vtama cream or a vehicle cream.
The results of the two trials showed that 45.4% and 46.4% of participants treated with Vtama achieved the primary endpoint, defined as a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least a 2-grade improvement from baseline. In comparison, only 13.9% and 18% of participants treated with the vehicle cream reached the same endpoint.
Furthermore, 55.8% of Vtama-treated participants met the key secondary endpoint which meant they achieved a 75% or greater improvement in the Eczema Area and Severity Index (EASI75) from baseline at week 8.
Adelaide A. Hebert, MD, professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program, states, “VTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease. Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream.”
