Raj Chovatiya, MD, PhD: Discussing the FDA Approval of Roflumilast for Atopic Dermatitis

After the US Food and Drug Administration (FDA) approved roflumilast cream .15% for the treatment of patients aged 6 years and up with atopic dermatitis, known colloquially as eczema, the HCPLive editorial team spoke with Raj Chovatiya, MD, PhD.^1,2

Chovatiya, a clinical associate professor of medicine at the Rosalind Franklin University of Medicine and Science, spoke in the interview about the new topical treatment’s significance for eczema patients in the age range indicated. Chovatiya highlighted several elements about the drug, first noting the rise of new options for patients with this skin condition.

“It's been hard not to be excited by atopic dermatitis in the past several years, because in both the systemic and topical realm, we're now getting more and more targeted treatment options,” Chovatiya explained. “This comes on the heels of essentially only having broad acting immunosuppressive agents like corticosteroids available to us for many, many years prior. I would say that the approval…is a watershed moment for the field of atopic dermatitis, in that it hopefully is going to set a trend for more studies and more approvals that are trying to include younger ages of kids alongside adolescents and adults.”

Chovatiya added that the condition of atopic dermatitis, known to impact millions of children and adults in the US and around the world, may be better served with a new topical option. He noted that topical corticosteroids, which themselves are associated with various issues in terms of tolerability, long-term use, or potency, are not the only solution needed for patients with the condition.

“Roflumilast is a phosphodiesterase-4 inhibitor and has much higher binding potential as an inhibitor than perhaps we were used to seeing from previous phosphodiesterase-4 inhibitors,” Chovatiya said. “It’s exciting because it really targets an adaptive immune mechanism that's important to the disease state and one that's important across age groups.”

Chovatiya also noted several key points about the drug’s addition to the dermatologist armamentarium.

“So number one, it's flexibility across adults, adolescents, and kids,” he explained. “Two, it's a cream and we know that a lot of the medications we use are ointments, but this is actually a highly, elegantly-designed cream that really has tried to eliminate many of the emulsifiers that are quite irritating, along with some of the other components, like propylene glycol, that have been issues for other topicals in the past.”

Chovatiya highlighted the fact that the drug’s potential ability to deliver something tolerable and easy to apply in a package that delivers efficacy is important.

“Third, the fact that this is a non-steroidal, and we can't emphasize this enough, is huge,” Chovatiya said. “Particularly in the pediatric age group where we know that there oftentimes can be a lot of concern about long term use of topical corticosteroids and limitations on the potency you can really use in various parts of the body, especially for longer periods of time. Something like a topical phosphodiesterase-4 inhibitor like roflumilast allows you to really avoid some of the consequences you don't want from use of strong topical corticosteroids.”

Chovatiya added a fourth point, which is that clinicians in the dermatology space are trying to raise their expectations for efficacy in the short run, but also implement something which is easy to use in the long run. He added that a drug which is helpful with intermittent use when patients are under control has been something that has been lacking as well.

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

The quotes contained here were edited for the purposes of clarity.

References

1. ^{FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. Arcutis Biotherapeutics, Inc. June 9, 2024. https://www.globenewswire.com/en/news-release/2024/07/09/2910781/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-15-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-Down-to-6-Years-of-Age.html. Date accessed: June 9, 2024.}
2. ^{Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older." Arcutis. Published September 12. https://www.arcutis.com/arcutis-submits-roflumilast-cream-0-15-supplemental-new-drug-application-to-the-fda-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-ages-6-years-and-older/.}