Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age
19 déc. 2022 08h00 HE
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Arcutis Biotherapeutics, Inc.
Regulatory submission for the expanded indication is supported by data from two recently completed 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2 to 11 years with plaque...
Study Showing Significant Improvements in Itch and Itch-Related Sleep Loss with Roflumilast Cream in Adults with Plaque Psoriasis Published in American Journal of Clinical Dermatology
28 nov. 2022 08h00 HE
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Arcutis Biotherapeutics, Inc.
Newly published phase 2b trial data show those treated with roflumilast cream had significantly greater improvements in itch compared to those treated with vehicle by Week 2 as assessed by the Worst...
Arcutis’ ZORYVE® (Roflumilast) Cream 0.3% Added to Express Scripts, Inc.® National Formularies in the United States
17 nov. 2022 08h00 HE
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Arcutis Biotherapeutics, Inc.
ZORYVE is now on formulary for one of the top pharmacy benefit managers serving commercially insured patients, effective November 18, 2022ZORYVE is a once-daily non-steroidal cream and the first and...
CORRECTION -- Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older
15 nov. 2022 11h10 HE
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Arcutis Biotherapeutics, Inc.
Study met the primary endpoint and all secondary endpointsFor the primary endpoint, 32.0% of individuals treated with roflumilast cream 0.15% achieved Investigator Global Assessment (IGA) Success...
Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older
15 nov. 2022 08h00 HE
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Arcutis Biotherapeutics, Inc.
Study met the primary endpoint and all secondary endpointsFor the primary endpoint, 32.0% of individuals treated with roflumilast cream 0.15% achieved Investigator Global Assessment (IGA) Success...
Journal of the American Medical Association Publishes Roflumilast Cream 0.3% Results from Pivotal DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis
20 sept. 2022 11h07 HE
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Arcutis Biotherapeutics, Inc.
Roflumilast cream showed higher efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of Investigator Global Assessment (IGA) success, with 40% of roflumilast cream...
Arcutis Completes Enrollment in INTEGUMENT-2 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis
23 août 2022 08h00 HE
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Arcutis Biotherapeutics, Inc.
A total of 683 adults and children, age 6 years and older, have been enrolled in the INTEGUMENT-2 trialTopline data from both INTEGUMENT-1 and -2 trials expected by end of 2022Atopic dermatitis affects...
Arcutis Launches ZORYVE™ (Roflumilast) Cream 0.3% in the United States for Treatment of Plaque Psoriasis in Individuals Age 12 and Older
10 août 2022 09h00 HE
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Arcutis Biotherapeutics, Inc.
Next-generation topical PDE4 inhibitor for adults and adolescents with plaque psoriasis now available in pharmacies nationwideEffective, safe, and very well-tolerated steroid-free cream that rapidly...
Arcutis Completes Enrollment in INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis
04 août 2022 08h00 HE
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Arcutis Biotherapeutics, Inc.
A total of 654 adults and children, age six and older, have been enrolled in the INTEGUMENT-1 trialEnrollment continues in INTEGUMENT-2 with topline data from both trials expected by end of 2022Atopic...
FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older
29 juil. 2022 16h05 HE
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Arcutis Biotherapeutics, Inc.
First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis Approved for once-daily treatment in mild, moderate, and severe plaque...