FDA Extends Review of Organon's VTAMA for Atopic Dermatitis
核心洞察
The FDA has extended the review period for Organon's sNDA for VTAMA (tapinarof) cream, 1% for treating atopic dermatitis (搜索) (AD) in adults and children aged two and older.
The new target action date is set for March 12, 2025, a three-month extension from the original date of December 12, 2024, due to the submission of additional data.
Organon remains confident in the efficacy and safety data supporting VTAMA for AD and anticipates approximately $125 million in revenue from VTAMA in 2025.
Organon's supplemental New Drug Application (sNDA) for VTAMA (tapinarof) cream, 1%, aimed at treating atopic dermatitis (搜索) (AD) in adults and children aged two years and older, has been extended by the U.S. Food and Drug Administration (FDA). The target action date is now March 12, 2025, a shift from the initial date of December 12, 2024.
The FDA's decision to extend the review period came after the agency requested and received final datasets and a clinical study report from the long-term extension study for VTAMA. The FDA classified this additional information as a major amendment to the sNDA, resulting in the standard three-month extension.
Juan Camilo Arjona Ferreira, MD, Head of Research & Development at Organon, stated, "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 to ensure the agency has all the information it needs for its review."
Financial Impact
With the revised PDUFA date, Organon anticipates that VTAMA will contribute approximately $125 million in revenue for the full year 2025. However, the company also projects an approximate 75 basis point headwind to Adjusted EBITDA margin in 2025. A more detailed financial outlook for 2025, including revenue growth and expense optimization plans, is expected in February 2025, when Organon reports its full-year 2024 results.
About Atopic Dermatitis
Atopic dermatitis (搜索), commonly known as eczema, is a prevalent inflammatory skin condition affecting over 26 million people in the U.S. and up to 10% of adults globally. It is particularly common in children, affecting up to 20% worldwide. The disease is characterized by itchy, red, swollen, and cracked skin, often affecting areas such as the folds of the arms, back of the knees, hands, face, and neck. The intense itching associated with AD can worsen at night, disrupting sleep and causing fatigue, which can lead to inattention in school for children. The visibility and discomfort of the disease can also cause social and emotional distress.
About VTAMA (tapinarof) Cream, 1%
VTAMA cream is a non-steroidal, once-daily topical treatment. Its safety and effectiveness were initially evaluated in the PSOARING-1 and 2 trials for plaque psoriasis (搜索), which are randomized, double-blind, vehicle-controlled studies. The ADORING-1 and ADORING-2 Phase III clinical studies also assessed VTAMA's safety and efficacy for treating atopic dermatitis (搜索); these results are currently under FDA review.
Safety Information
VTAMA (tapinarof) cream, 1%, is an aryl hydrocarbon receptor (搜索) agonist indicated for the topical treatment of plaque psoriasis (搜索) in adults. It is for topical use only and should not be applied to the eyes, mouth, or vagina. Common adverse reactions (incidence ≥ 1%) observed in subjects treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. Patients are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.