2023 Eczema Treatment Roundup

2023 proved to be another exciting year for eczema medications. Since our last roundup in December 2022, the Food and Drug Administration (FDA) approved a new age indication for an existing treatment and, at the time of publication, was expected to approve a new treatment for eczema. There are also many promising new therapies rounding the corner to FDA review in 2024.

New eczema treatment developments in 2023

• New age indication for Cibinqo (abrocitinib). Cibinqo (abrocitinib), an oral JAK1 inhibitor originally approved by the FDA in January 2022 for adults with refractory moderate to severe atopic dermatitis, was approved for adolescents ages 12 and older in February 2023.

• New age indication for Adbry (tralokinumab-ldrm). Adbry (tralokinumab-ldrm), a biologic drug originally approved by the FDA in December 2021 for adults with moderate to severe atopic dermatitis, was approved for adolescents ages 12 and older in December 2023.

• First prescription treatment for seborrheic dermatitis. At the time of publication, FDA review of roflumilast foam 0.3% from manufacturer Arcutis Biotherapeutics is anticipated on or around the PDUFA action date of December 16, 2023. Roflumilast foam 0.3% is a once-daily topical, a selective phosphodiesterase-4 (PDE4) inhibitor and will be the first topical drug specifically for seborrheic dermatitis.

What to expect in 2024

• Nonsteroid topical. VTAMA (tapinarof), a new nonsteroid topical cream developed by Dermavant Sciences, is anticipated to be filed with the FDA in Q1 2024. VTAMA 1% has shown positive results from two Phase 3 trials in adults and children down to 2 years of age with moderate to severe atopic dermatitis. VTAMA is an aryl hydrocarbon receptor agonist.

• Roflumilast cream for atopic dermatitis. In addition to the submission of roflumilast foam 0.3% for seborrheic dermatitis referenced above, Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older. The sNDA will be reviewed in 2024.

• A new biologic. A new biologic treatment for atopic dermatitis was also anticipated in 2023, lebrikizumab from manufacturer Eli Lilly and Company. It had a PDUFA action date set for fall 2023, but a complete response letter issued by the FDA has since delayed that timeline. Lebrikizumab has shown positive results from its Phase 3 clinical development program in adult and adolescent patients ages 12 years and older with moderate to severe atopic dermatitis. Lebrikizumab is an IL-13 inhibitor.

Stay in the know

Stay up to date on the latest eczema therapies as they become available by visiting our website at NationalEczema.org/new-treatments. You can also find information on eczema treatments in development and learn more about where they are in the full treatment pipeline.