John Browning, MD: Potential Impact of FDA Acceptance of Tapinarof on Eczema Management

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During this interview segment, Browning highlighted the impact of a future FDA acceptance of tapinarof for atopic dermatitis as well as the next milestones in regulatory approval.

In another segment of his interview with the HCPLive editorial team, John Browning, MD, UT Health San Antonio adjunct associate professor, spoke about the potential impact of a US Food and Drug Administration (FDA) approval of tapinarof cream (Vtama) for patients aged 2 years and older with atopic dermatitis.

Browning’s discussion followed the FDA’s recent acceptance of the drug’s Supplemental New Drug Application (sNDA) as a once-daily therapy for patients with atopic dermatitis, a unique development given the drug’s current indication for psoriasis. Browning himself had participated in the ADORING trials prior to the FDA’s acceptance of the sNDA.

“For pediatric dermatologists like myself, it's very exciting to have a steroid-free option,” Browning stated. “Potentially getting approved in the future for atopic dermatitis, I can see tapinarof really being the gold standard first treatment that we give to a patient. We could bypass topical steroids altogether and that would be kind of the dream, in my mind.”

In the interview, Browning was asked about what impact he anticipated the acceptance of the sNDA for tapinarof cream and the possible approval by the FDA might have on the management and outcomes of atopic dermatitis in both adults and children.

“One of the findings in the adoring studies was a decrease in itch, which is huge,” he said. “That's really the number 1 symptom that kids and adults both complain about with their atopic dermatitis because it affects sleep and it affects your ability to participate in sports and in school. So just decreasing the itch and allowing them to have control of their skin, I think it's going to lead to a lot of happy patients.”

Looking ahead, Browning was asked what the next steps or milestones would be in the regulatory process following the acceptance of the drug’s sNDA, in addition to what the potential timelines for tapinarof cream would be in terms of availability for patients with eczema.

“Now that the sNDA has been filed, and there's such favorable data for the FDA to review,” he said. “Hopefully, we'll see approval of the drug and that's called a PDUFA date, which I believe is already set for late in the year. I don't know the exact date but hopefully the FDA will be able to review the data in a timely fashion so that they can hopefully approve the tapinarof for kids 2 and up for atopic dermatitis late this year.”

To learn more on this topic, view Browning’s full interview segment which has been posted above.

The quotes contained in this article 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.

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