Dermavant Submits Supplemental NDA for VTAMA (tapinarof) Cream, 1% for Atopic Dermatitis

February 14, 2024

Previously approved for plaque psoriasis, the treatment sets its sights on AD treatment.

Dermavant announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VTAMA (tapinarof) cream, 1% for treating atopic dermatitis (AD) in adults and children aged 2 years and older. 

The novel, aryl hydrocarbon receptor antagonist is being developed as a once-daily, steroid-free topical cream for both acute treatment and long-term management of AD. VTMA has been approved since 2022 for the treatment of mild, moderate, and severe plaque psoriasis in adults, making it at the time the first non-steroidal topical novel chemical entity in the U.S. in a quarter century. 

“The prevalence of atopic dermatitis, an extremely burdensome skin condition, continues to grow, and there is an increasing need for new, long-term, treatment options, especially for children,” said Todd Zavodnick, CEO of Dermavant, said in a news release. “Today’s submission of our sNDA marks a significant milestone as we work towards the approval of VTAMA cream for patients suffering from atopic dermatitis as well as the families and caregivers of these patients. We are confident, that VTAMA cream, if approved by the FDA, will be well positioned as a safe, well-tolerated, steroid-free topical treatment option for patients 2 years of age and older with AD and could provide for long-term disease management, representing meaningful advancement for patients, caregivers, and healthcare providers.”

The submission is supported by positive results from the phase 3 ADORING 1 and ADORING 2 trials, both randomized, vehicle-controlled pivotal studies, as well as data from the ADORING 3 open-label, long-term extension study. The treatment was shown to yield statistically significant improvement in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001), and was also associated with a significant improvement in the proportion of patients showing ≥75% improvement in Eczema Area and Severity Index (EASI75) from baseline to Week 8 compared with vehicle (P<0.0001). In patients of 12 and older, those receiving the treatment also saw significant improvements in itch as assessed by a ≥4-point improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2).

Researchers reported no new safety signals or tolerability issues. 

Source:  Dermavant press release. Published February 14, 2024. 

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