The FDA approved Dermavant Science's Vtama (tapinarof cream) last year as a treatment for plaque psoriasis. Sales have been disappointing, according to press reports. Will Vtama, which has a different mechanism of action than the current batch of topical medications for atopic dermatitis, fare better in the atopic dermatitis market?
Patients with atopic dermatitis have a growing number of choices when it comes to treatment. The FDA has approved four systemic therapies since 2017: Dupixent (dupilumab), Adbry (tralokinumab), Cibinquo (abrocitinib) and Rinvoq (upadacitinib). There’s also been a proliferation of different types of topical treatments for atopic dermatitis in addition to the old standby, topical corticosteroids. The topical treatments approved by the FDA include Protopic (tacrolimus ointment), Elidel (pimecrolimus cream), Eucrisa (crisaborole ointment) and Opzelura (ruxolitinib cream).
Now Dermavant Sciences, a Long Beach, California, company, is looking to add one more treatment to the armamentarium. The company’s main product, Vtama (tapinarof cream) was approved by the FDA last year as a treatment for plaque psoriasis in adults. The company announced earlier this month that it was preparing to file application for supplemental new drug application for Vtama (pronounced vee-TAM-uh) this quarter.
That announcement also included company-reported news of positive results from an interim analysis of an ongoing open-label trial designed to test Vtama as treatment for atopic dermatitis over a 48-week period. The company also trumpeted positive results from an analysis that melded results from two prior studies with the open-label study.
Fierce Pharma reported in November 2023 that sales of Vtama were below expectations created and that Leerink Partners, an investment bank that focuses on healthcare, had cut its 2032 Vtama sales projections for Vtama from a blockbuster-level of $1.4 billion to $407 million
“Vtama is struggling to catch on,” the news website said. The website for Vtama highlights in a large font that 225,000 prescriptions for cream had been written since it was launched by 12,000 prescribers and cites IQVIA as a source.
Drugs.com says the price of a 60-gram tube of Vtama is priced at about $1,468. The lowest price listed on GoodRx is $1,338.
An editorial published online on Jan. 11, 2024, in the Journal of Dermatological Treatment makes case for Vtama and its mechanism of action as aryl hydrocarbon receptor agonist. The editorial, which was written by four experts with consulting or investigator ties to Dermavant and discloses funding for editorial assistance from the company, describe the aryl hydrocarbon receptor as a “master regulator and communication node for multiple signaling pathways involved in skin homeostasis.” An article published in the same journal several years ago notes that topical coal tar, which has been used for centuries to calm inflammation cause by atopic dermatitis and psoriasis, has polycyclic hydrocarbons receptors that also activate aryl hydrocarbon receptors. “The AHR (aryl hydrocarbon receptor) pathway is a promising pharmacological target for developing a tidier alternative to messy coal tar,” wrote the authors the 2018 article.
The editorial points to some of the limitations of the current treatments for atopic dermatitis as well as positive results from the trials testing Vtama. None of the systemic treatments are approved for mild atopic dermatitis, according to lead author Lawrence F. Eichenfield, M.D., chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology, and his co-authors. Eichenfield and his co-authors list the drawbacks of the topical medications for atopic dermatitis as pain, burning and stinging where they are applied; restrictions on how long they can be used; and warnings and restrictions based on age and maximum body surface area. They also point to a schedule that requires two applications day and atopic dermatitis recurring after patients stop using the current batch of topical medications. In contrast, they cite results reported two years from the phase 3 PSOARING trial that show clear or almost clear skin four months after treatment with Vtama for psoriasis was stopped. “In the context of AD (atopic dermatitis) ,a mechanism of action with potential disease-modifying effects may be especially important for children where restoration of the skin barrier could impact allergic sensitization and the atopic march and offer the opportunity for treatment-free periods, “ wrote Eichenfield and his colleagues.
The Dermavant news release earlier this month said that just over half (51.2%) of 728 patients in the open-label study, called ADORING 3, achieved complete disease clearance in an interim analysis and that at 56 weeks, there no additional signs that the medication was harmful or caused series side effects.
The news release also listed a series of positive results from a study that focused on 711 people with mild to severe atopic dermatitis who were enrolled in two previous phase 3 trials, called ADORING 1 and ADORING 2, the ADORING 3, or a fourth study.Among the positive results reported by Dermavant were that 80.7% (574 of 711) of the study participants included in that analysis achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75).