AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata

AbbVie

28 April 2026 - Submission is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of severity of alopecia tool (SALT) score ≤ 20 at week 24, with additional efficacy results observed at week 52.

AbbVie today announced that it has submitted an application for a new indication to the US FDA for upadacitinib (Rinvoq, 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata, based on results from the Phase 3 UP-AA clinical program.

Read AbbVie press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration