HQ Team
November 5, 2024: The US regulator has extended a review of an application by Organon & Co.’s atopic dermatitis (eczema) drug by three months with a new target date set for March next year.
The review of the New Drug Application for Vtama (tapinarof) cream for the treatment of dermatitis in adults and children two years and older has been revised from December 12, 2024, to March 12, 2025, according to a company statement.
The FDA has not raised any concerns regarding the safety and efficacy of Vtama cream, a non-steroidal once-daily topical treatment. The regulator has also not raised any concerns regarding the approvability of this indication.
As part of its review process, the Food and Drug Adaministration requested the final datasets and clinical study report from the long-term extension study for Vtama.
Additional information
After receiving the datasets, the FDA determined that the additional information requested constituted a major amendment to the sNDA resulting in a standard three-month extension to the original target action date.
“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 atopic dermatitis and we are committed to working with the FDA to ensure the agency has all the information it needs for its review,” said Juan Camilo Arjona Ferreira, MD, Head of Research & Development at Organon.
With the extension, the company expects that revenue contribution for Vtama for the full year 2025 will be approximately $125 million, according to the statement.
“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.”
Itching
Atopic dermatitis, commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the US alone and up to 10% of adults worldwide.
It occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck.
Itching tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with eczema may also experience social and emotional distress due to the visibility and discomfort of the disease.
