ABBV AbbVie Inc

By Michael Dabaie

AbbVie on Friday said it submitted applications seeking approvals for upadacitinib to the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of adults with active non-radiographic axial spondyloarthritis.

The applications are supported by the Phase 3 SELECT-AXIS 2 clinical trial, the company said.

Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life, AbbVie said.

In the trial, upadacitinib met its primary and most ranked secondary objectives. Treatment with upadacitinib 15 mg once daily resulted in reductions in signs and symptoms of nr-axSpA, including back pain and inflammation, as well as improvements in physical function and disease activity at week 14 versus placebo.

In addition, AbbVie has requested label enhancements for upadacitinib in the European Union to include adult patients with active ankylosing spondylitis who had an inadequate response to biologic disease-modifying anti-rheumatic drugs.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

January 07, 2022 09:36 ET (14:36 GMT)

AbbVie (NYSE:ABBV)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024

AbbVie (NYSE:ABBV)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024