FDA accepts sNDA for tapinarof cream, 1% to treat AD in children 2 years and up

FDA accepts sNDA for tapinarof cream, 1% to treat AD in children 2 years and up | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

Tapinarof cream, 1% (VTAMA; Dermavant Sciences) has taken another step in the FDA approval process, as the federal agency has accepted the supplemental New Drug Application (sNDA) for the potential topical treatment of atopic dermatitis in adults and children aged 2 years and older.¹

With the acceptance of the sNDA, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date to be in the 4th quarter of 2024, according to Dermavant.¹

"Tapinarof, the active ingredient in [tapinarof] cream, 1%, is a novel drug demonstrating a proposed new mechanism of action potentially for atopic dermatitis, showing positive safety data, efficacy, and good tolerance in the atopic dermatitis clinical studies from ages 2 years-plus, which complements the data and experience of its use in the topical treatment of plaque psoriasis in adults," said Lawrence Eichenfield, MD, in a previous interview with Contemporary Pediatrics.²

Eichenfield, a professor of dermatology and pediatrics, vice chair, Department of Dermatology, chief, Pediatric and Adolescent Dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego, California, added, "The addition of a highly effective topical, steroid-free medication that decreases inflammation and itch rapidly compared to vehicle, and effectively, could be very helpful in managing AD in children and adolescents."²

Data from the ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) phase 3 trials supported the sNDA. The trials are identical, double-blind, randomized, and vehicle-controlled.^1,3

In January, Dermavant announced results from an integrated analysis spanning the ADORING development program, also including the on-going ADORING 3 open-label, long-term extension study evaluating safety and efficacy of tapinarof cream, 1% in AD patients for up to 48 weeks.³

Overall, the integrated analysis revealed that 73% achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear), with at least a 2-grade improvement from baseline. Nearly 81% of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75).³

For patients aged 12 years and older, 77.9% with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or greater achieved a 4-point or greater reduction in PP-NRS.³

In October 2023, Dermavant released new pruritus data for tapinarof cream, 1% that revealed a greater reduction in itch as early as 24 hours after first application in children as young as 2 years of age with AD.⁴

"Overall, these results show a rapid reduction in itch as early as 24 hours after first application of tapinarof, with a consistent improvement in itch through week 8," Eric Simpson, MD, MCR, professor, Frances J. Storrs Medical Dermatology, director, CLEAR Eczema Center, Oregon Health & Science University, told Contemporary Pediatrics at the time.⁴

"Itch remains the most burdensome and prevalent symptoms of atopic dermatitis, and these results highlight the potential of tapinarof as a clinically meaningful therapy with the ability to reduce itch for adults and children living with atopic dermatitis," said Simpson.

Click here for full 24-hour application results and full commentary from Simpson.⁴

In March, Dermavant announced positive data from the ADORING program for adult and pediatric patients down to 2 years of age with skin of color. Click here for these results.

References:

1. Dermavant announces FDA acceptance of supplemental New Drug Application (sNDA) for VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. Dermavant Sciences. Press release. April 29, 2024. Accessed April 29, 2024. https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/

2. Fitch, J. Reaction to tapinarof cream, 1% sNDA submission with Lawrence Eichenfield, MD. Contemporary Pediatrics. February 15, 2024. Accessed April 29, 2024. https://www.contemporarypediatrics.com/view/reaction-tapinarof-cream-1-snda-submission-lawrence-eichenfield-md

3. Fitch, J. New topline phase 3 data for tapinarof cream 1% to treat AD in children. Contemporary Pediatrics. January 11, 2024. Accessed April 29, 2024. https://www.contemporarypediatrics.com/view/new-topline-phase-3-data-for-tapinarof-cram-1-to-treat-ad-in-children

4. Fitch, J. Tapinarof cream 1% reduces itch as early as 24 hours after application for pediatric AD. Contemporary Pediatrics. October 13, 2023. Accessed April 29, 2024. https://www.contemporarypediatrics.com/view/tapinarof-cream-1-reduces-itch-as-early-as-24-hours-after-application-for-pediatric-ad