Beth Snyder Bulik
Senior Editor

AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker.

While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug.

The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission.

AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation.”

Rinvoq (upadacitinib) was first approved in 2019 to treat rheumatoid arthritis but has since racked up indications in psoriatic arthritis, atopic dermatitis, ulcerative colitis, ankylosing spondylitis and axial spondyloarthritis.

The drug, along with IL-23 blocker Skyrizi, is part of AbbVie’s next generation of anti-inflammatory meds, following up on its blockbuster Humira which is approved in more than 10 indications, including Crohn’s, UC and rheumatoid and psoriatic arthritis, but lost patent protection in the US this year.

While Humira revenues are declining, Skyrizi and Rinvoq are on the upswing — although still far from replacing the peak of $21.2 billion in Humira sales recorded in 2022. In AbbVie’s most recent Q1 report, Skyrizi garnered $1.36 billion while Rinvoq had sales of $686 million, and Humira, although dropping year over year at $3.59 billion, still led AbbVie immunology revenue.