FDA Extends Review of Organon's Vtama for Atopic Dermatitis to March
Key Insights
The FDA has extended the review period for Organon's Vtama cream for treating atopic dermatitis (search), setting a new target action date for March 12.
The extension was prompted by the FDA's request for final datasets and the clinical-study report from a long-term extension study.
Organon anticipates Vtama will contribute approximately $125 million in revenue next year due to the delay, impacting 2025 earnings.
Organon announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its supplemental New Drug Application (sNDA) seeking approval of Vtama (tapinarof) cream for the treatment of atopic dermatitis (search). The FDA has set a new target action date of March 12, 2025.
The extension was initiated by the FDA to allow for a thorough review of the final datasets and clinical study report from a long-term extension study. Organon acquired Vtama as part of its acquisition of Dermavant Sciences (search) from Roivant Sciences (search) in October.
Vtama is a novel, non-steroidal, topical cream. It was initially approved by the FDA for the treatment of plaque psoriasis (search) in 2022. The current sNDA seeks to expand its indication to include atopic dermatitis (search), a chronic inflammatory skin condition affecting millions of Americans. Organon had anticipated a decision by the end of 2024.
According to Organon, the FDA has not expressed any concerns regarding the safety or efficacy of Vtama, nor have they indicated any issues with the approvability of the new indication. Despite this, the delay will impact Organon's financial projections for Vtama. The company now expects Vtama to contribute approximately $125 million in revenue in 2025, a decrease from the previously forecasted $150 million. Additionally, the Dermavant deal is projected to reduce Organon's 2025 adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) margin by approximately 75 basis points, compared to the earlier estimate of 50 basis points.
Impact on Revenue Projections
The delay in FDA approval will lead to a reduction in Organon's expected revenue contribution from Vtama in the coming year. While the company remains optimistic about the drug's potential, the revised timeline necessitates adjustments to financial forecasts.
Vtama's Potential in Atopic Dermatitis
Atopic dermatitis (search) is a common and often debilitating skin condition characterized by inflammation, itching, and skin lesions. Current treatments include topical corticosteroids, calcineurin inhibitors, and systemic therapies. Vtama offers a non-steroidal option that could provide relief for patients who do not respond well to existing treatments or who are seeking alternatives to steroids.