AbbVie (NYSE: ABBV), a United States-based biopharmaceutical company, announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for its RINVOQ (upadacitinib) to treat moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to earlier treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.
RINVOQ 15mg once daily can be initiated in adults and children 12 years of age and older weighing around 40kg. Dose is likely to be increased to 30mg once daily in these children and adults less than 65 years of age who do not achieve an adequate response.
Abbvie says that the FDA approval is supported by efficiency and safety data from one of the largest registrational Phase three programs for atopic dermatitis with over 2,500 patients assessed across three studies.
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