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FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis
The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.
The FDA has accepted a supplemental New Drug Application (sNDA) from Dermavant for tapinarof cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. A Prescription Drug User Fee Act date is expected in the fourth quarter of 2024.1
"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," said Todd Zavodnick, CEO of Dermavant, in a news release. "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."1
Imge credit: Марина Терехова | stock.adobe.com
The acceptance is based on positive findings from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.1
Tapinarof cream, 1% is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, steroid-free, topical cream for both acute and long-term management of atopic dermatitis. On May 24, 2022, it received FDA approval for the treatment of plaque psoriasis in adults, making it the first non-steroidal novel chemical entity launched for psoriasis in the US in more than 25 years.1
According to findings published in the Annals of Allergy, Asthma, and Immunology, tapinarof cream 1%, administered once-daily, demonstrated statistically significant and clinically meaningful itch improvements for both adults and children 2 years of age and older with moderate to severe atopic dermatitis. The trials achieved all primary and secondary end points and was well tolerated, according to the study results.2
In the ADORING 1 and 2 trials, 407 and 406 patients, respectively, were randomized 2:1 to tapinarof cream 1% of vehicle cream once-daily for 8 weeks. Secondary and additional end points included proportion of patients who achieved clinically meaningful ≥4-point reduction in Pek Pruritus-Numerical Rating Scale (PP-NRS) score at week 8.2
At baseline, mean PP-NRS scores were 6.4, 6.9-7.2, and 6.7-6.8 for patients aged ≥12 years, <12 years, and all patients, respectively. At week 8, a ≥4-point reduction in PP-NRS was achieved by significantly higher proportions of patients in all tapinarof groups compared with vehicle groups. Patients aged ≥12 years saw reductions of 55.8% vs 34.2% and 52.8% vs 24.1%; patients aged <12 years saw reductions of 60.7% vs 28% and 60% vs 40.8%; and all patients saw reductions of 61.1% vs 34% and 57.4% vs 33%, in the ADORING 1 and 2 trials, respectively.2
Topline results from an open-label maximal usage study, annouced in November of 2022, were also quite positive. The study enrolled 36 patients aged 2 to 17 years old with a validated Investigator Global Assessment scale score ≥3 at screening. Participants received 4 weeks of treatment with tapinarof cream, 1% once-daily. Notably, the same dose and frequency has been approved by the FDA for topical treatment of adult plaque psoriasis.3
According to those study findings, tapinarof cream, 1% demonstrated favorable safety, pharmacokinetic, and clinical improvement in atopic dermatitis in subjects as young as 2 years of age. There was a low incidence of adverse events and it was well tolerated, even in sensitive skin areas. Minimal to no systemic exposure was confirmed under maximal use conditions in subjects with up to 90% body surface area affected.3
