Organon's Vtama Cream Approved for Atopic Dermatitis

Organon has successfully expanded the labeling of Vtama, a topical cream it acquired in an acquisition from Dermavant last October. The U.S. Food and Drug Administration (FDA) has now greenlit Vtama, scientifically referred to as tapinarof, for the treatment of atopic dermatitis in both adults and children aged two years and above. The approval came sooner than anticipated, following a temporary delay by the agency the previous month due to the requirement for additional data from a long-term extension study, with an original decision expected in March.

The acquisition deal between Organon and Dermavant was valued at $1.2 billion, inclusive of an upfront payment of $175 million and a contingent milestone payment of $75 million upon FDA approval for atopic dermatitis. Moreover, the agreement encompassed potential commercial milestone payouts amounting to as much as $950 million.

Initially gaining FDA approval in 2022 for the treatment of adults suffering from plaque psoriasis, Vtama's expansion into the atopic dermatitis market signifies a significant milestone. Dermavant, formerly part of Roivant, highlighted the potential of the atopic dermatitis market, noting it to be substantially larger—three to four times—than the market for plaque psoriasis. As per data from Roivant, Vtama has achieved significant traction, with over 385,000 prescriptions issued for plaque psoriasis by May 2024.

The journey of Vtama traces back to 2018 when Vivek Ramaswamy's team orchestrated the acquisition of the drug from GlaxoSmithKline (GSK) for an upfront payment of approximately $200 million. This strategic movement underscores the evolving landscape of dermatological treatments and showcases Vtama’s growing role in addressing skin conditions. The expansion into treating atopic dermatitis opens up larger market opportunities and reinforces Organon's foothold in the therapeutic area.

Organon’s proactive maneuvering, coupled with the FDA’s timely approval, positions them advantageously in a rapidly expanding segment of dermatology. The focus now shifts to optimizing the commercial rollout and maximizing patient reach with this newly approved indication, ensuring that those suffering from atopic dermatitis have access to efficient and steroid-free treatment options.