Discussing the Potential Approval of Tapinarof for Atopic Dermatitis with John Browning, MD

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In this interview, Browning discusses his team’s trial data and the implications of the FDA’s decision to accept the supplemental new drug application for tapinarof as an eczema treatment.

In late April, the US Food and Drug Administration’s (FDA) acceptance of Dermavant Science’s Supplemental New Drug Application (sNDA) for once-daily tapinarof cream, 1% (Vtama) was announced and the drug was indicated for atopic dermatitis treatment of adults and children aged 2 years or older.

The sNDA filing for the novel, aryl hydrocarbon receptor agonist was supported by ADORING 1 and ADORING 2 phase 3 findings, the drug’s open-label maximal usage pharmacokinetics study, and the ADORING 3 open-label extension trial findings. In a new interview with HCPLive, John Browning, MD, UT Health San Antonio adjunct associate professor and ADORING trial investigator, spoke on these findings and the sNDA.

“In the ADORING trials…we looked at kids 2 years of age and older with atopic dermatitis and what we found is that after 8 weeks, about 45% of them were clear or almost clear,” Browning explained. “That was a really great finding, and we also found that about 55% were 75% better than their baseline, so even in the ones that weren't clear or almost clear, there was significant improvement. We also looked at a variety of different skin types and skin of color patients.”

Browning highlighted the diversity of the trial program, noting that during the ADORING 3 trial, half of the patients had a darker skin type and the results remained comparable.

“We found in this long term trial that many patients could actually be off of their tapinarof for long periods of time, where they could be free of flares and not have to use anything, so I think that was a unique finding that I'm really excited about,” Browning added.

Browning was later asked about what distinguishes tapinarof cream as a topical treatment for atopic dermatitis, particularly in comparison to other existing treatments.

“Tapinarof is distinguished because it is based on an actual molecule and there's really great safety data,” Browning explained. “So unlike other steroid-free options that might have a black box warning on them, or might have limitations as to how long you can use them…But it is very unique to have a steroid free product that can be used every day, if needed, and you can stop it when you don't need it.”

Browning was also asked, given that tapinarof cream is already FDA-approved for plaque psoriasis, how its approval for atopic dermatitis might help to expand treatment options for patients and healthcare providers.

“The company that makes (tapinarof) decided to pursue approval first for psoriasis, which kind of surprised me because I think psoriasis, at least in the topical arena, as a somewhat more difficult condition to treat because the plaques of psoriasis are thicker,” he said. “I would expect a topical anti-inflammatory to be able to work faster in atopic dermatitis but they chose to pursue approval in psoriasis…I've been able to use it for my adult psoriasis patients with really happy patients. What they realized was that same inflammatory pathway. It works along with the aryl hydrocarbon pathway. So when the (tapinarof) is able to change inflammation and downgrade it, it can do that both for psoriasis as well as atopic dermatitis.”

For additional information on this topic, view the full interview segment posted above.

The quotes contained in this summary were edited for clarity. Browning is an investigator for Amryt, Arcutis, Brickell Biotech, Celgene, ChemoCentryx, Dermavant, Eli Lilly, Incyte, Lenus Pharma, LEO Pharma, Mayne Pharma, Novartis, Pfizer, Regeneron, and Valeant; a consultant for Dermavant and LEO Pharma; and a speaker for Dermira, Regeneron, and Pfizer.