Organon announced on November 5, 2024, that the U.S. Food and Drug Administration (FDA) extended the target action date for its review of the supplemental New Drug Application (sNDA) for VTAMA (tapinarof) cream, 1%. The review, which seeks approval for atopic dermatitis (AD) in adults and children two years of age and older, now has a new target date of March 12, 2025, extended from December 12, 2024.
The extension was prompted by the FDA's request for final datasets and the clinical study report from the long-term extension study for VTAMA. The FDA determined this additional information constituted a major amendment to the sNDA, leading to a standard three-month extension.
Organon maintains confidence in the submitted efficacy and safety data package for VTAMA in AD. However, as a result of this delay, the company now expects VTAMA's revenue contribution for the full year 2025 to be approximately $125 million, a reduction from the prior commentary of $150 million. The transaction is also expected to result in an approximate 75 basis point headwind to Adjusted EBITDA margin in 2025, compared to a prior estimate of 50 basis points.
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