The FDA has blessed two previously approved medicines—one a cream and the other an injection—to treat atopic dermatitis (AD). Both products now will be available to a significantly larger patient population as roughly 26 million in the U.S. have the disorder, which is also known as eczema.
Organon’s Vtama, a topical cream originally approved for plaque psoriasis in 2022, is now cleared to treat AD, the company said early Monday. The nod came three months after New Jersey-based Organon acquired the product in a $1.2 billion takeover of Dermavant.
Similarly, the FDA gave a thumbs-up to Galderma’s Nemluvio to treat AD. The drug, a monthly subcutaneous injection, was previously endorsed by the U.S. regulator for prurigo nodularis.
The label expansion for Vtama—which opens the treatment up to patients age 2 and older—came well ahead of its target action date of March 12, 2025.
Organon paid $175 million upfront for Dermavant in September and now owes another $75 million for kicking Vtama over the goal post in AD. Another $950 million is on the table if Organon achieves designated commercial milestones. Organon also will pay Dermavant shareholders tiered royalties on net sales.
Dermavant was established in 2015 as a dermatology-focused subsidiary of Roivant Sciences, a Switzerland-based hub-and-spoke company founded by former Republican presidential candidate Vivek Ramaswamy.
The new nod triples Vtama’s patient population and was based on results from a phase 3 trial of 728 patients. The study showed that the steroid-free treatment enabled 51% of recipients to achieve disease clearance after 48 weeks.
The approval could help spark stagnant sales of Vtama, which has not lived up to analyst expectations as a novel, aryl hydrocarbon receptor agonist. In August, Roivant reported its quarterly sales at $18.4 million, which was down from sales of $19.3 million in the previous period.
“It’s not a matter of if, it’s when,” Dermavant CEO Todd Zavodnick told Fierce Pharma in November of 2023 about the potential of Vtama. “Psoriasis got us to the dance and AD is gonna allow us to unlock the blockbuster, game-changing status.”
As for Nemluvio, the FDA endorsement opens its use up to patients age 12 and older with moderate to severe atopic dermatitis. It's approved for use in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
Nemluvio is the first approved monoclonal antibody that specifically targets IL-31, a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation.
Galderma picked up Nemluvio in a licensing deal with Roche subsidiary Chugai Pharmaceutical in 2016.