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FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

ARQT
  • The FDA has approved a supplemental New Drug Application for ZORYVE (roflumilast) cream 0.3% to treat plaque psoriasis, including intertriginous areas, in children as young as 2 years old.
  • ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for pediatric plaque psoriasis patients down to age 2.
  • The medication is safe, effective, well-tolerated, & suitable for use anywhere on the body with no restrictions on duration of use.
  • This represents the seventh FDA approval for ZORYVE in four years by Arcutis Biotherapeutics.
  • The expanded indication is based on data from the 4-week MUSE study (ARQ-151-216) & long-term safety data from an open-label extension study (ARQ-151-306) in children ages 2 to 5 years.
  • Clinical results showed safety & efficacy profiles consistent with those observed in pivotal Phase 3 trials involving adolescents & adults.
  • Prior to this approval, ZORYVE cream was indicated for plaque psoriasis in adults & children down to age 6.
  • The drug is a topical formulation of roflumilast, a selective phosphodiesterase type 4 (PDE4) inhibitor that reduces pro-inflammatory mediators.
  • Common adverse reactions for ZORYVE cream 0.3% include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), & urinary tract infection (1.0%).
  • ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
  • Arcutis offers the ZORYVE Direct Program & Arcutis Cares patient assistance program to help with insurance navigation, adherence, & cost reduction for eligible patients.
  • ZORYVE cream 0.3% is widely available through key wholesaler & dermatology pharmacy channels.