FDA extends target action date for Vtama cream sNDA for atopic dermatitis

Key takeaways:

• The FDA’s decision did not mention efficacy, safety or approvability as a reason for the extension.
• The target action date has been extended 3 months to approximately March 12, 2025.

The FDA has extended the target action date of its review of the supplemental new drug application for Vtama cream 1% for the treatment of atopic dermatitis in adults and children aged at least 2 years, Organon announced in a press release.

According to the release, the FDA’s decision to postpone the target action date was not due to a concern over efficacy, safety or approvability of Vtama (tapinarof) cream.

Instead, the FDA determined additional information was needed before reviewing the application. Because the requested information constitutes a major amendment to the sNDA, the agency applied a 3-month extension to the original target action date as is standard practice in these situations.

“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,” Juan Camilo Arjona Ferreira, MD, head of R&D at Organon, said in the release.

The announcement now moves the target action date to March 12, 2025.