Vtama receives FDA approval for atopic dermatitis

Key takeaways:

• Vtama cream 1% is a nonsteroidal topical treatment now approved for atopic dermatitis and psoriasis.
• Phase 3 trials found most patients treated with Vtama to have reduced itch and increased skin clearance.

The FDA has approved Vtama cream 1% for atopic dermatitis in adults and children aged 2 years and older, Organon announced in a press release.

“Topical therapies remain a cornerstone for treating atopic dermatitis (AD) whether patients have mild, moderate or severe disease. But there remains an unmet need for safe, effective and tolerable non-steroidal topical therapies that can be used in both adults and pediatric patients,” Mona Shahriari, MD, assistant clinical professor of dermatology at Yale University School of Medicine, told Healio.

The FDA’s decision was based on data from the phase 3 ADORING trials in which Vtama (tapinarof) cream, a once-daily, steroid-free, aryl hydrocarbon receptor agonist, showed significant reductions in itch and improvement in skin clearance.

A validated IGA for AD (vIGA-AD) score of 0 or 1 with a 2-grade or greater improvement, was found to occur in 45.4% and 46.4% of patients treated with Vtama in the two trials, respectively, compared with 13.9% and 18% of those treated with vehicle cream (P < .0001 for both).

Additionally, 51.9% of patients who entered the long-term extension ADORING 3 trial achieved vIGA-AD 0 at least once and 81.6% achieved vIGA-AD 0 or 1 during the trial, according to Shahriari.

“With this approval, both adults and pediatric patients down to 2 years of age will have access to a new topical option for AD that is effective and safe for long-term use, improves bothersome symptoms such as itch, and offers the potential for complete disease clearance and potentially treatment-free days regardless of severity,” Shahriari said.

There are few steroid-free topical treatments for AD, “particularly in young children,” she added.

“Moreover, treatment regimens in the younger age groups can be complex necessitating the use of multiple topicals on various body sites for varying lengths of time,” Shahriari continued. “This approval provides access to an innovative cosmetically elegant topical treatment option for AD that has demonstrated clinical benefits across age groups down to 2 years of age, a variety of skin types and racial backgrounds, and has the potential to simplify the treatment regimen for our patients with AD.”

Vtama, which was developed by Dermavant Sciences and acquired by Organon in September, was previously approved by the FDA for the treatment of plaque psoriasis in adults.

Reference:

• Organon to acquire Dermavant including its innovative dermatologic therapy, Vtama (tapinarof) cream, 1%. https://www.organon.com/news/organon-to-acquire-dermavant-including-its-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/. Published Sept. 18, 2024. Accessed Dec. 16, 2024.