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Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months

Arcutis Biotherapeutics (ARQT)Arcutis BiotherapeuticsFDA / regulatory

Submission supported by data from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis Once-daily ZORYVE cream was well tolerated with a safety profile consistent with that in older children and adults Atopic dermatitis

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Arcutis Biotherapeutics

Medical Dermatology Arcutis Biotherapeutics develops and commercializes targeted therapies for immune-mediated skin diseases, emphasizing convenient topical formulations against validated biology. ZORYVE Franchise ZORYVE is a once-daily topical roflumilast product available in cream and foam formulations across plaque psoriasis, atopic...

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FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months

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26.43 USD
Market cap
2.6B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States