PDUFA Date for Tapinarof 1% Cream in Atopic Dermatitis Pushed to 2025

Image Credit: © JHVEPhoto - stock.adobe.com

Organon announced today that the US Food and Drug Administration (FDA) has extended the target action date by 3 months for its supplemental New Drug Application (sNDA) for tapinarof (Vtama) cream, 1% for patients aged 2 years and older with atopic dermatitis (AD).¹

The FDA has requested additional information related to the long-term extension study data on the drug, including final datasets and the clinical study report from the trial. However, the organization did not cite any concerns with the safety and efficacy of tapinarof.

Earlier this year, Dermavant Sciences announced that the FDA had accepted for review its sNDA for tapinarof cream 1% with this indication. The FDA's initial Prescription Drug User Fee Act (PDUFA) date was anticipated in the fourth quarter of 2024, with a target action date initially established as December 12, 2024.²

Now, the 3-month extension has pushed the expected PDUFA date to March 12, 2025.

The sNDA for the novel topical treatment is supported by data from 2 pivotal phase 3 clinical trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), along with an open-label pharmacokinetics trial in children and interim analysis results from the ongoing ADORING 3 trial.

"The landscape of atopic dermatitis management is evolving, offering hope for the millions affected, especially children. Currently, over 9.6 million kids in the US struggle with AD, experiencing relentless itching and scratching. However, finding safe and effective treatments, especially ones without steroids, remains a significant challenge," said John Browning, MD, FAAD, FAAP, a board-certified dermatologist at Texas Dermatology and Laser Specialists, adjunct associate professor at UT Health San Antonio, an assistant professor at Baylor College of Medicine, and clinical faculty at UIW School of Medicine, in a previous interview with Dermatology Times.

With the revised PDUFA date now set for March, Organon anticipates that Vtama will contribute approximately $125 million in revenue during the full year of 2025. However, this anticipated revenue may also represent an approximate 75 basis point headwind to the company’s Adjusted EBITDA margin for that year.

The company plans to provide further insights into its consolidated financial performance, including anticipated revenue growth and expense optimization strategies, in February 2025 when they report their full-year results for 2024.

"Organon remains confident in the robust efficacy and safety data package that has been submitted to the agency to support the review of Vtama for AD and we are committed to working with the FDA ensure the agency has all the information it needs for its review," said Organon's Head of Research & Development, Juan Camilo Arjona Ferreira, MD, in a news release.¹

References

1. Update on FDA review of Vtama (tapinarof) cream 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. BusinessWire. November 5, 2024. Accessed November 5, 2024. https://www.businesswire.com/news/home/20241105332994/en/Update-on-FDA-Review-of-VTAMA%C2%AE-tapinarof-Cream-1-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-2-Years-of-Age-and-Older
2. 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. News release. Dermavant Sciences. April 29, 2024. Accessed November 5, 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/