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Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

FDA has set a target action date of December 16, 2023NDA supported by positive efficacy and safety data from the Phase 2 and pivotal Phase 3 trials of roflumilast foamIf approved, roflumilast foam... | April 18, 2023
Frank Watanabe Amanda Sheldon Drug Administration Arcutis Biotherapeutics Inc Head Of Corporate Communications Exchange Commission

Arcutis Announces Positive Topline Results from Second Atopic Dermatitis Pivotal Phase 3 Trial of Roflumilast Cream in Adults and Children Aged 6 and Older

12.12.2022 - Study met the primary endpoint and key secondary endpoints, consistent with positive topline results from the INTEGUMENT-1 trial released in NovemberFor the primary endpoint, 28.9% of individuals treated with roflumilast cream 0.15% achieved ...
Amanda Sheldon Exchange Commission Head Of Corporate Communications Arcutis Biotherapeutics Inc Eczema Area Severity Index

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Arcutis Announces Positive Topline Results from ARRECTOR Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Scalp and Body Psoriasis

Study met both co-primary endpoints and all secondary endpointsAt week eight, 67.3% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment Success compared to... | September 26, 2022
United States Eric Mcintyre Amanda Sheldon Exchange Commission Head Of Corporate Communications Globenewswire Inc

New Data from Arcutis' STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis Presented at European Academy of Dermatology and Venereology (EADV) Congress

Study met its primary endpoint with 80% of individuals treated with roflumilast foam achieving Investigator Global Assessment Success compared to 59% of patients treated with vehicle More than 60% of... | September 9, 2022
Amanda Sheldon Drug Administration Exchange Commission Academy Of Dermatology Head Of Corporate Communications Parcutis Biotherapeutics Inc

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