Arcutis submits new drug application for roflumilast for seborrheic dermatitis treatment
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A new drug application submitted to the FDA seeks approval of roflumilast foam 0.3% for adults and adolescents with moderate to severe seborrheic dermatitis, Arcutis Biotherapeutics announced in a press release.
“Despite its prevalence and impact, there remains a significant unmet need for new options to treat seborrheic dermatitis,” Patrick Burnett, MD, PhD, FAAD, senior vice president and chief medical officer at Arcutis, told Healio. “Today, individuals are often left to manage their symptoms with multiple treatments and complex application routines.”
If approved, roflumilast foam 0.3%, a nonsteroid, phosphodiesterase-4 inhibitor, would be the first topical drug for seborrheic dermatitis with a new mechanism of action in more than 20 years.
According to the release, the submission is based on results from Arcutis’ pivotal phase 3, parallel group, double blind, vehicle-controlled STRATUM trial evaluating the safety and efficacy of roflumilast foam 0.3%. According to the release, the study showed an IGA success rate of 79.5% in roflumilast-treated patients vs. 58% in those treated with vehicle by week 8. Additionally, 51.3% of roflumilast-treated patients reached an IGA score of clear by the study’s completion.
Roflumilast demonstrated a favorable safety profile with mild to moderate treatment-emergent adverse events that were comparable between groups.
According to Burnett, Arcutis anticipates that the FDA will provide a target action date for approval in late 2023.
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