EUCRISA ointment becomes the first and only steroid-free topical prescription drug in the United States, approved for 3-month-old patients
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Last Update: 2020-05-29
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Source: Internet
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Author: User
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The U.SFood and Drug Administration (FDA) approved Pfizer's 2% EUCRISA (Crisaborole) ointment supplementary new drug application (SNDA), extending it to children with mild to moderate atopic dermatitis (AD) (also known as eczema) for more than 3 monthsEUCRISA has previously been approved for use in adults and children over 2 years of ageThis supplementary approval makes EUCRISA the first and only steroid-free local prescription drug for 3-month-old patients with mild to moderate ADAD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects that affect about 11% of children in the United States2% Crisaborole ointment is a new steroid-free local phosphoacidestase (PDE4) inhibitorRichard Blackburn, global president ofPfizer Inflammation and Immunology, said: "Although isotrophic dermatitis usually occurs in infancy, there are few approved treatment options for this population todayWe are committed to making a meaningful difference in the lives of our patients, and as this adaptation expands, we can help many children with eczemathe approval ofEUCRISA Expanded Indications is based on data from a Phase 4 clinical study designed to assess the safety and efficacy of Crisaborole in infants with mild to moderate AD during 3 months to 24 monthsIn this study, 2% of Crisaborole ointments were well tolerated and confirmed in patients with mild to moderate AD
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