Arcutis Biotherapeutics Announces Long-Term Results From INTEGUMENT-OLE Study, Showing Durable Efficacy And Favorable Safety Of Roflumilast Cream 0.05% In Treating Mild To Moderate AD In Children; 71.9% Achieved EASI-75 After 56 Weeks; Plans sNDA Submission To FDA In Q1 2025
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Arcutis Biotherapeutics reported positive long-term results from its INTEGUMENT-OLE study, demonstrating the efficacy and safety of Roflumilast Cream 0.05% for treating mild to moderate atopic dermatitis in children. The company plans to submit a supplemental New Drug Application (sNDA) to the FDA in Q1 2025.
August 28, 2024 | 12:07 pm
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Arcutis Biotherapeutics announced positive long-term results for Roflumilast Cream in treating atopic dermatitis in children, with plans for an sNDA submission to the FDA in Q1 2025.
The positive long-term results and the plan to submit an sNDA to the FDA are likely to boost investor confidence in Arcutis Biotherapeutics. The achievement of EASI-75 by 71.9% of participants indicates strong efficacy, which could lead to future market approval and potential revenue growth.
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IMPORTANCE 80
RELEVANCE 100