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Roflumilast cream receives FDA approval for use in pediatric patients with plaque psoriasis
By Ella Dixon
On October 6, 2023, the U.S. Food and Drug Administration (FDA) approved roflumilast cream 0.3%,1 a topical phosphodiesterase-4 inhibitor,2 for use in pediatric patients aged between 6 and 11 years with plaque psoriasis.1 This follows the approval of roflumilast cream in patients with plaque psoriasis aged 12 years or older in July 2022.2
This expanded indication follows positive results from a 4-week maximal usage systemic exposure study in pediatric patients with plaque psoriasis.1 Safety and efficacy data were similar to the DERMIS-1 and DERMIS-2 trials (NCT04211363; NCT04211389) in adult patients with plaque psoriasis. Future studies will assess roflumilast safety and efficacy in patients aged 2 to 5 years old.
Roflumilast cream is currently the only available treatment for plaque psoriasis that is specifically indicated for use in intertriginous areas.1
- FDA approves Arcutis’ ZORYVE® (roflumilast) cream 0.3% for treatment of psoriasis in children ages 6 to 11. https://www.globenewswire.com/news-release/2023/10/06/2756044/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-Treatment-of-Psoriasis-in-Children-Ages-6-to-11.html. Published Oct 6, 2023. Accessed Oct 9, 2023.
- International Psoriasis Council. Arcutis announces FDA approval for ZORYVE (roflumilast) cream 0.3% for plaque psoriasis in individuals age 12 and older. https://psoriasiscouncil.org/industry/arcutis-zoryve-press-release/. Published Aug 9, 2022. Accessed Oct 9, 2022.
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