Organon & Co. (NYSE:OGN) Receives Three-Month Extension from FDA for VTAMA® Review

Organon & Co. (NYSE:OGN) recently announced that the U.S. Food and Drug Administration (FDA) has extended the target action date for the review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1%. The FDA’s revised target action date is now set for March 12, 2025, extending from the original target date of December 12, 2024. During this review process, the FDA has conveyed no safety and efficacy concerns about VTAMA or its approvability for treating atopic dermatitis in adults and children two years and older.

As part of the review, the FDA requested final datasets and a clinical study report from the long-term extension study for VTAMA. Upon receiving these, the FDA categorized the additional information as a major amendment to the sNDA, prompting the standard three-month extension to the original target action date.

Organon remains confident in the effectiveness and safety of VTAMA and is dedicated to supporting the FDA during the review process. Juan Camilo Arjona Ferreira, MD, the Head of Research & Development at Organon, reiterated the company’s commitment to providing the FDA with all necessary information for the review.

With the assumed PDUFA (Prescription Drug User Fee Act) date now set for March 12, 2025, Organon estimates that VTAMA will contribute approximately $125 million to the company’s revenue for the full year 2025. Additionally, the company foresees this extension impacting the Adjusted EBITDA margin by approximately 75 basis points in 2025.

For a more comprehensive outlook on Organon’s expected financial performance in 2025, including revenue growth and expense optimization plans, investors can expect further details in February 2025 when the company reports its full-year 2024 results.

VTAMA® cream, 1% is a non-steroidal once-daily topical treatment that has undergone evaluation in clinical studies for plaque psoriasis and atopic dermatitis. The most common adverse reactions reported during trials were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

Concerning forward-looking information, this press release notes that the FDA approval process and potential implications surrounding such approvals are subject to risks and uncertainties. Organon emphasizes that actual results could differ from the forward-looking statements provided. Investors and stakeholders are encouraged to refer to Organon’s filings with the Securities and Exchange Commission (SEC) for a more in-depth analysis of these risks and uncertainties.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Organon & Co.’s 8K filing here.

About Organon & Co.

Organon & Co develops and delivers health solutions through a portfolio of prescription therapies and medical devices within women's health in the United States and internationally. Its women's health portfolio comprises contraception and fertility brands, such as Nexplanon, a long-acting reversible contraceptive; NuvaRing, a monthly vaginal contraceptive ring; Cerazette, a daily pill used to prevent pregnancy; Marvelon, progestin and estrogen used as daily pills to prevent pregnancy; Follistim AQ, used to promote the development of multiple ovarian follicles in assisted reproduction technology procedures; Elonva, an ovarian follicle stimulant; Ganirelix Acetate Injection, an injectable antagonist; and Jada, for abnormal postpartum uterine bleeding or hemorrhage.