AbbVie Files for Expanded Approval of Skyrizi in Ulcerative Colitis

by Warren Seah

AbbVie, the biopharmaceutical company based in North Chicago, Illinois, has submitted applications for expanded approval of its widely successful autoimmune medication Skyrizi. The company seeks approval from both the U.S. Food and Drug Administration and the European Medicines Agency to allow Skyrizi to be used in the treatment of adults with moderately to severely active ulcerative colitis.

To support these filings, AbbVie presents two Phase 3 studies which demonstrate that Skyrizi achieved clinical remission as well as key secondary endpoints. The data validated Skyrizi’s efficacy as both an induction and maintenance treatment for individuals suffering from this chronic inflammatory bowel disease.

With global revenue reaching $3.24 billion for the first half of this year, Skyrizi has already received approval for its use in the United States and Europe to treat plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

AbbVie is notably depending on Skyrizi, along with another autoimmune drug called Rinvoq, to compensate for declining sales of their mega-blockbuster product, Humira. Humira, which holds the title of the highest-grossing drug in history, is now facing competition from generic alternatives after patent expiration.

Earlier this year, AbbVie set an ambitious sales target for Rinvoq and Skyrizi by 2025, aiming to surpass $17.5 billion in revenue. The majority of this target is attributed to Skyrizi, which is predicted to generate more than $10 billion in sales alone.

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