Dermavant: FDA Accepts sNDA for Tapinarof Cream 1% for Treatment of Adults, Children with Atopic Dermatitis

Dermavant Sciences announced today that the company’s supplemental new drug application (sNDA) for tapinarof (Vtama) cream 1% for the treatment of atopic dermatitis (AD) in adults and children aged 2 years and older has been accepted by the US FDA. Dermavant submitted the sNDA in February this year and the FDA has now assigned a PDUFA date in the fourth quarter of 2024^.1

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Vtama cream, 1% is approved in the US for topical treatment of plaque psoriasis in adults and this is the same strength and formulation now being studied in the Dermavant ADORING phase 3 development program evaluating the topical for treatment of AD.

Data for the Dermavant sNDA submission is from 3 sources, according to the announcement: the pivotal phase 3 ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) clinical trials, identical, double-blind, randomized, vehicle-controlled, studies; an open-label maximal usage pharmacokinetics trial in children aged 2 to 17 years; and the interim analysis of ADORING 3, a phase 3, 48-week, open-label, extension trial.¹

“The FDA acceptance of our sNDA is an important milestone in our efforts to bring Vtama cream, as a potentially safe and well-tolerated non-steroidal treatment. option, to adults and children as young as 2 years old who suffer from atopic dermatitis. Our commitment to patients is unwavering, and we remain highly focused on preparing for the commercial launch of Vtama cream, subject to FDA approval, for its second indication of atopic dermatitis,” Todd Zavodnick, chief executive officer of Dermavant, said in the news release.¹

Tapinarof cream is a novel, aryl hydrocarbon receptor agonist that, if approved, will be indicated for both acute treatment and long-term management of AD. The original approval of tapinarof for plaque psoriasis in May 2022 made it the first non-steroidal, novel chemical entity topical agent available to treat psoriasis in the US in more than 25 years.¹

“Nonsteroidal topicals, like Vtama cream, have really challenged the treatment paradigm and I have seen a shift in my personal dermatology practice where I reach for Vtama over topical corticosteroids...As someone who sees the physical and emotional impact that chronic skin conditions can have on patients daily, I’m excited about the innovations we’re witnessing within the topical treatment landscape,” Mona Shahriari, MD, assistant clinical professor of dermatology at the Yale School of Medicine, the associate director of clinical trials at Central Connecticut Dermatology Research, and member of Patient Care partner site Dermatology Times’ editorial advisory board.²

The interim analysis of the 48-week ADORING 3 study (n = 711), reported in January 2024,3 found that tapinarof efficacy continued to improve beyond the 8-week double-blind treatment periods in the ADORING 1 and 2 trials across several endpoints.³ More than half (51.2%) of study participants achieved complete disease clearance as determined by a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0.2.³

Nearly three-quarters (73%) of participants reached a vIGA-AD score of clear or almost clear with at least 2 grades of improvement from baseline.³ Further, 92.3% of the participants achieved at least a 1-point improvement in vIGA-AD scoring. Eczema Area and Severity Index (EASI) scores also improved. Approximately 80.7% of participants reached EASI-75.³

ADORING 3 researchers also reported a mean itch reduction as early as 24 hours after tapinarof cream application, with 77.9% of participants who had presented with a Peak Pruritus Numeric Rating Scale (PP-NRS) score of equal to or greater than 4 achieving a minimum 4-point PP-NRS score reduction.³

The long-term use of tapinarof cream was well tolerated and there were no new safety signals reported, according to Dermavant. Adverse events were predominantly mild to moderate in nature, with no serious events related to treatment reported. The discontinuation rate attributed to adverse events was low at 2.6%.³

References

1. Dermavant announces FDA acceptance of supplemental new drug application (sNDA) for VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Dermavant. April 29, 2024. Accessed April 29, 2024.
ttps://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/
2. Bader K, Shahriari M. Clinician and Patient Perspective: Tapinarof Cream for Plaque Psoriasis. Dermatology Times. April 26, 2024. https://www.dermatologytimes.com/view/clinician-and-patient-perspective-tapinarof-cream-for-plaque-psoriasis
3. Dermavant announces positive data from the ADORING phase 3 development program in atopic dermatitis with VTAMA (tapinarof) cream, 1% in adults and children as young as 2 years old. News release. Dermavant. January 11, 2024. Accessed April 29, 2024. https://dermavant.com/dermavant-announces-positive-data-from-the-adoring-phase-3-development-program-in-atopic-dermatitis-with-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as-2-years-old/