The U.S. Food and Drug Administration (FDA) has extended their review of the supplemental New Drug Application (sNDA) for tapinarof cream, 1% (Vtama, Organon) as a treatment for atopic dermatitis (AD) in adults and children two years of age and older by three months.
The new target action date is March 12, 2025, revised from the original target action date of December 12, 2024.
The FDA has not raised any concerns regarding the safety and efficacy of tapinarof cream, 1% nor have they raised any concerns regarding the approvability of this indication.
As part of its review process, the FDA requested the final datasets and clinical study report from the long-term extension study for tapinarof cream, 1%. After receiving the datasets, the FDA determined that the additional information requested constitutes a major amendment to the sNDA resulting in a standard three-month extension to the original target action date.
“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,” says Juan Camilo Arjona Ferreira, MD, Head of Research & Development at Organon, in a news release.
With an assumed PDUFA date of March 12, 2025, the company expects that revenue contribution for tapinarof cream, 1% for the full year 2025 will be approximately $125 million and that the transaction will result in an approximate 75 basis point headwind to Adjusted EBITDA margin in 2025. This is an update to the company’s prior commentary, provided during its third quarter earnings call held on October 31, 2024. The company will provide a more detailed outlook for 2025 expected consolidated financial performance, including revenue growth and expense optimization plans, in February 2025 when it reports full year 2024 results.
