FDA Review Update: VTAMA® (tapinarof) Cream for Atopic Dermatitis in Adults and Children 2+

Organon, a global healthcare company focused on improving women's health, has announced an extension to the U.S. Food and Drug Administration's (FDA) review period for its supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% for treating atopic dermatitis in individuals aged two and older. The revised target action date is now set for March 12, 2025, pushed back from December 12, 2024. This extension results from the FDA's request for additional data, which includes the final datasets and clinical study report from a long-term extension study of VTAMA. The FDA considers this new information a major amendment, thus necessitating the standard three-month extension for review.

Organon's Head of Research & Development, Juan Camilo Arjona Ferreira, MD, expressed confidence in the comprehensive data supporting VTAMA's safety and efficacy for atopic dermatitis. He reaffirmed the company's commitment to collaborating with the FDA to ensure a thorough review process.

Given the new projected approval date, Organon anticipates that VTAMA will contribute approximately $125 million in revenue for the full year 2025. Additionally, the transaction is expected to negatively impact the Adjusted EBITDA margin by about 75 basis points in the same year. A more detailed financial outlook for 2025, including revenue growth and expense optimization, will be provided by the company in February 2025 when it announces its full year 2024 results.

Atopic dermatitis, also known as eczema, is a prevalent inflammatory skin condition that affects over 26 million people in the United States and up to 10% of adults globally. It is particularly common among children, with a worldwide prevalence of up to 20%. The disease manifests as itchy, red, swollen, and cracked skin, typically affecting areas like the arms, knees, hands, face, and neck. The itching associated with atopic dermatitis is particularly troublesome, often worsening at night and leading to sleep disturbances and fatigue. This can further impact children's attention and performance in school. Additionally, the visible symptoms of the disease can cause significant social and emotional distress.

VTAMA cream, a non-steroidal, once-daily topical treatment, has been previously evaluated for its safety and efficacy in treating plaque psoriasis through the PSOARING-1 and 2 clinical trials. Its effectiveness for atopic dermatitis has also been assessed in the ADORING-1 and ADORING-2 Phase III clinical studies and is currently under FDA review. The cream is an aryl hydrocarbon receptor agonist intended for external use only and should not be applied to the eyes, mouth, or vaginal areas. Adverse reactions reported in clinical studies include folliculitis, nasopharyngitis, contact dermatitis, headache, itching, and influenza.

Organon, headquartered in Jersey City, New Jersey, is dedicated to addressing women's health issues through a diverse portfolio of over 60 medicines and products. The company also focuses on biosimilars and various established medicines, while continuously investing in innovative solutions and research for future growth, especially in women's health and biosimilars. Organon leverages its global reach, extensive commercial capabilities, and a workforce of approximately 10,000 employees to collaborate with biopharmaceutical partners and innovators aiming to commercialize their products in rapidly growing international markets.