FDA Accepts Tapinarof Cream sNDA for Atopic Dermatitis Patients Aged 2 Years and Older

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The announcement by Dermavant followed positive findings from the ADORING trials on tapinarof and an open label extension for children aged 2 - 17.

Biopharmaceutical company Dermavant Sciences announced the US Food and Drug Administration’s acceptance of the company’s Supplemental New Drug Application (sNDA) for tapinarof cream, 1% (Vtama) for atopic dermatitis in both adults and children aged 2 years and older.1

The company’s announcement also noted that tapinarof’s Prescription Drug User Fee Act (PDUFA) action date is slated for the fourth quarter of 2024. The drug’s sNDA acceptance by the FDA follows recent positive findings from recent phase 3 trial data assessing tapinarof’s use in atopic dermatitis.

“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,” Todd Zavodnick, Dermavant’s Chief Executive Officer, said in a statement.

Atopic dermatitis, written interchangeably as eczema, is a common inflammatory skin disease which is known to impact close to 16.5 million adults as well as more than 9.6 million US children. The Dermavant announcement noted that given around 80% of eczema cases begin prior to the age of 6, the drug may become available for children as young as 2 if it receives FDA approval.

The cream itself is a new aryl hydrocarbon receptor agonist which was formulated as a once-per-day, steroid-free topical option for dermatologists’ armamentarium as both an immediate and long-term treatment option for eczema. The drug has already been FDA-approved for plaque psoriasis treatment among US adults.

The submission by Dermavant followed positive phase 3 findings drawn from the ADORING 1 and ADORING 2 trials, as well as data from an open-label pharmacokinetics trial in which children in the age range of 2 - 17 were evaluated. The sNDA submission also followed an interim analysis from the ADORING 3 trial, a phase 3 extension study lasting 48-weeks.

Dermavant had been granted an approval by FDA officials in May 2022 for tapinarof cream, 1% for plaque psoriasis in adults, thereby making the treatment the first non-steroidal topical option in the US for patients with psoriasis in more than 2 decades. This approval by the agency had been the result of positive findings in the PSOARING 1 and PSOARING 2 trials.2

Tapinarof was noted by officials with Dermavant as being formulated for moderate and severe psoriasis cases. They added that there were no specific label safety warnings or restrictions on treatment duration or patient body surface area.1

The same formulation and strength used in treating psoriasis is now under investigation following the sNDA submission to FDA officials for atopic dermatitis, given tapinarof’s results in the phase 3 ADORING trial program.

The announcement included a note about the most common adverse events (AEs) for those who did experience AEs when taking tapinarof (incidence ≥ 1%). These included contact dermatitis, headaches, nasopharyngitis, folliculitis, pruritus, and influenza.

“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,” Zavodnick said in a statement.

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. Dermavant Sciences. April 29, 2024. https://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/. Date accessed: April 29, 2024.
  2. Butera A. FDA Approves Tapinarof Cream, 1% for Adults with Plaque Psoriasis. HCPLive. May 24, 2022. https://www.hcplive.com/view/fda-approves-tapinarof-cream-adults-plaque-psoriasis. Date accessed: April 29, 2024.
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