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AbbVie Submits Application for Upadacitinib as Alopecia Areata Treatment to FDA

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AbbVie (ABBV) submitted to the US Food and Drug Administration an application for upadacitinib's new indication as treatment for adult and adolescent patients with severe alopecia areata, the company said Tuesday.

The company said it used data from a phase 3 trial of upadacitinib, also known as Rinvoq, to support the application. The trial met its primary endpoint of a severity of alopecia tool score of less than or equal to 20 at week 24, AbbVie said.

Upadacitinib's safety profile in the trial was also consistent with previously announced study results, the company added.

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