Lawrence Eichenfield, MD, reacts to the FDA's acceptance of a supplemental New Drug Application for roflumilast cream 0.15% to treat atopic dermatitis (AD) in patients aged 6 years and older.
In this Contemporary Pediatrics® interview, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, vice chair, Department of Dermatology, chief, Pediatric and Adolescent Dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego, reacts to the FDA's acceptance of a supplemental New Drug Application (sNDA) for roflumilast cream 0.15% (Arcutis Biotherapeutics) to treat atopic dermatitis (AD) in patients aged 6 years and older.
Interview transcript (edited for clarity):
What is your reaction to the FDA accepting the sNDA of roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years and up?
Lawrence Eichenfield, MD:
AD is a complex disease and there's this incredible range in severity of AD and while we have incredible new systemic medicines to help us with our more severe patients, most patients still will be using topical therapy, and many of them can be effectively managed with topical therapies.
But we've had some needs in regard to that because there is still incredible concern about topical corticosteroids. You can't use them for extended periods of time, there's unfortunately, I'd say even more concern about topical corticosteroids being fed by social media that is making people think that exacerbations of their eczema may be due to the topical steroids, where it could just be the natural disease. Not to take away that some individuals truly can have a steroid withdrawal phenomenon.
Looking for newer nonsteroidal agents that can bring efficacy and safety is something that's really important. Certainly, having those medicines approved down to younger ages is really important.
The announcement of the FDA accepting the sNDA for roflumilast [0.15%], plus other work with that drug and other drugs, with different formulations and different agents, I think will be very important going forward to have a newer set of nonsteroidal medicines for AD.