FDA Expands Pediatric Roflumilast Use - Summary - MDSpire
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FDA Expands Pediatric Roflumilast Use
The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.
To announce the FDA's approval of roflumilast cream 0.3% for the treatment of plaque psoriasis in pediatric patients aged 2 years and older.
Approach:
Study Overview: The approval was based on data from the open-label, 4-week Maximal Usage Systemic Exposure (MUSE; ARQ-151-216) study and additional long-term safety data from the open-label extension study (ARQ-151-306).
Key Findings:
Roflumilast cream 0.3% is now approved for pediatric patients aged 2 years and older.
The therapy was previously approved for adults and children aged 6 years and older at a 0.15% dose.
Safety and efficacy findings were consistent with those in phase 3 trials for adolescents and adults.
Interpretation:
Limitations:
Roflumilast cream 0.3% is contraindicated in patients with moderate to severe liver impairment.
