AbbVie Gets FDA Approval for Rinvoq for Ages 12 and Older

By Chris Wack

AbbVie Inc. said the U.S. Food and Drug Administration has approved Rinvoq upadacitinib for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older.

The company said Rinvoq 15 mg once daily can now be initiated in adults and children 12 years of age and older weighing at least 40 kg. In those children and adults less than 65 years of age who don't achieve an adequate response, the dose may be increased to 30 mg once daily.

AbbVie said the FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis, with more than 2,500 patients evaluated across three studies. About 52% of the patients had prior exposure to systemic atopic dermatitis treatment.

These studies evaluated the efficacy and safety of Rinvoq monotherapy and with topical corticosteroids, compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

January 14, 2022 13:49 ET (18:49 GMT)

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