By Colin Kellaher


AbbVie has filed for expanded U.S. and European approval of its blockbuster autoimmune drug Rinvoq for the treatment of adults with giant cell arteritis, an inflammatory disease that can cause headache, jaw pain and changes in vision, including sudden and permanent vision loss.

AbbVie on Friday said its applications with the Food and Drug Administration and European Medicines Agency are supported by results from a Phase 3 study in which Rinvoq, combined with a steroid taper regimen, achieved its primary endpoint of sustained remission.

The company said there are currently few approved treatment options for giant cell arteritis, adding that most patients are managed with glucocorticoids, with many unable to discontinue them without the recurrence of symptoms.

AbbVie is counting on Rinvoq and fellow blockbuster autoimmune drug Skyrizi to help make up for lost sales of its megablockbuster Humira, which lost U.S. patent protection last year.

The North Chicago, Ill., biopharmaceutical company in February said it now expects combined Skyrizi and Rinvoq revenue to top $27 billion in 2027, up from prior guidance of $21 billion.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

07-12-24 0916ET