FDA accepts supplemental NDA for Vtama cream for atopic dermatitis in adults, children
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Key takeaways:
- Data from the ADORING trials and a pharmacokinetics trial contributed to the application acceptance.
- A Prescription Drug User Fee Act date has been set for the fourth quarter of this year.
The FDA has accepted Dermavant Science’s supplemental new drug application for Vtama cream 1% for the treatment of atopic dermatitis in adults and children aged 2 years and older, the company announced in a press release.
Currently approved for the topical treatment of adults with plaque psoriasis, Vtama (tapinarof) cream 1% is a once-daily, novel, steroid-free, aryl hydrocarbon receptor agonist is currently being developed for both acute treatment and long-term management of atopic dermatitis.
The FDA has set a Prescription Drug User Fee Act date for the fourth quarter of this year.
“The FDA acceptance of our [supplemental new drug application] is an important milestone in our efforts to bring Vtama cream, as a potentially safe and well tolerated nonsteroidal treatment option, to adults and children as young as 2 years old who suffer from atopic dermatitis,” Todd Zavodnick, CEO of Dermavant, said in the 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.”
The application is supported by phase 3 data from two identical, double-blind, randomized trials, ADORING 1 and ADORING 2. The application is also supported by an open-label maximal usage pharmacokinetics trial in children aged 2 to 17 years as well as the interim results of the phase 3, 48-week extension ADORING 3 trial.
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