ABBV AbbVie Inc

By Colin Kellaher

AbbVie has filed for U.S. and European expanded approval of its blockbuster autoimmune drug Skyrizi for the treatment of adults with moderately to severely active ulcerative colitis.

The North Chicago, Ill., biopharmaceutical company on Monday said the filings with the U.S. Food and Drug Administration and European Medicines Agency are backed by a pair of Phase 3 studies in which Skyrizi met the primary endpoint of clinical remission and key secondary endpoints as an induction and maintenance treatment for the chronic inflammatory bowel disease.

AbbVie reported global revenue of $3.24 billion for the first six months of the year for Skyrizi, which is already approved in the U.S. and Europe for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease.

AbbVie is relying on Skyrizi and fellow autoimmune drug Rinvoq to make up for lost sales for its mega-blockbuster Humira, the highest-grossing drug of all time that now faces competition from copycats after patent expirations.

AbbVie earlier this year raised its 2025 risk-adjusted sales target for Rinvoq and Skyrizi to more than $17.5 billion, including more than $10 billion for Skyrizi.

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

(END) Dow Jones Newswires

August 28, 2023 09:35 ET (13:35 GMT)

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