Organon reports FDA extension of target action date of review of Vtama sNDA

Organon (OGN) announced that the FDA extended by three months the target action date of its review of the supplemental New Drug Application, or sNDA, for Vtama cream, 1% as a treatment for atopic dermatitis in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12. The FDA has not raised any concerns regarding the safety and efficacy of Vtama 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 Vtama. 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. With an assumed PDUFA date of March 12, 2025, the company expects that revenue contribution for Vtama for the full year 2025 will be approximately $125M 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.