Dermavant submits new drug application for tapinarof cream in atopic dermatitis
Key takeaways:
- Tapinarof cream 1% is already approved for treating adults with plaque psoriasis.
- Treatment led to improved Validated Investigator Global Assessment for Atopic and Eczema Area and Severity Index scores.
Dermavant Sciences has submitted a supplemental new drug application to the FDA for its Vtama cream 1% for the topical treatment of atopic dermatitis in patients aged 2 years and older, according to a company press release.
Vtama (tapinarof) cream 1% is a novel, aryl hydrocarbon receptor agonist designed for once-daily acute treatment and long-term management of AD, the company said. Currently, it is approved for the topical treatment of plaque psoriasis in adults.
“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,” Todd Zavodnick, Dermavant CEO, said in the release.
The submission is supported by data from the pivotal phase 3 ADORING 1 and 2 trials and by interim data from ADORING 3. Approximately 80% of the participants in ADORING 1 and 2 were pediatric patients aged younger than 18 years.
ADORING 1 and 2 indicated statistically significant improvements in Validated Investigator Global Assessment for Atopic Dermatitis scores of 0 (clear) or 1 (almost clear), with at least a two-grade improvement from baseline at week 8, compared with vehicle (P < .0001 for both).
There also were statistically significant improvements in the proportion of patients with improvements of 75% or more in Eczema Area and Severity Index from baseline to week 8 compared with vehicle (P < .0001 for both).
Patients aged 12 years and older experienced statistically significant improvements in itch as categorized by a four-point improvement or more in patient-reported Peak Pruritus Numeric Rating Scale scores compared with vehicle as well (P = .0366 for ADORING 1 and P = .0015 for ADORING 2).
There were no safety or tolerability signals of concern in the cohort, which included patients aged 2 years and older, with mostly mild to moderate adverse events and a low study discontinuation rate due to adverse events.