On Oct. 6, the This marks an expanded indication for the drug, which was first approved for the same indication in July, 2022, for individuals aged 12 and older.
Roflumilast cream 0.3% is a phosphodiesterase-4 inhibitor approved for once-daily topical treatment of mild, moderate, and severe plaque psoriasis. According to a press release from the manufacturer, Arcutis Biotherapeutics, approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children ages 6-11 years with plaque psoriasis. It stated that pharmacokinetic, safety, tolerability, and efficacy data from this study were “generally consistent” with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adults.
According to the press release, a future FDA review is planned for the results from a second MUSE study in children ages 2-5 years, as well as data from an ongoing open-label extension study evaluating the long-term safety of roflumilast cream in individuals with plaque psoriasis aged 2 years and older. The company markets topical roflumilast as Zoryve.