The FDA has accepted Arcutis Biotherapeutics Inc's (NASDAQ:ARQT) marketing application seeking approval for roflumilast cream for psoriasis in adults and adolescents.
- The FDA assigned the application a Prescription Drug User Fee Act target action date of July 29, 2022.
- Roflumilast cream (ARQ-151) is a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses.
- Related: Arcutis Stops ARQ-252 Vitiligo Trial After Formulation-Related Observations In Chronic Hand Eczema Study.
- Arcutis' NDA submission is supported by data from Arcutis' pivotal Phase 3 program and a long-term Phase 2b open-label study. DERMIS 1 and DERMIS 2 Phase 3 studies evaluated the safety and efficacy of roflumilast cream 0.3%.
- Roflumilast met its primary endpoint and had an Investigator Global Assessment (IGA) success rate of 42.4% compared to a vehicle rate of 6.1% and 37.5% compared to a vehicle rate of 6.9%, in DERMIS 1 and 2, respectively.
- Price Action: ARQT shares closed at $18.54 on Wednesday.
