AbbVie's Rinvoq Wins Expanded FDA Approval for Crohn's Disease
The approval strengthens the drug's market position as a key growth driver, helping the biopharma giant navigate the post-Humira era.
AbbVie (NYSE: ABBV) has secured an expanded U.S. Food and Drug Administration (FDA) approval for its key immunology drug, Rinvoq, for the treatment of adult patients with moderately to severely active Crohn's disease. The decision marks a significant milestone for the ~$407 billion biopharmaceutical company, broadening the drug's label and reinforcing its role as a cornerstone of AbbVie's growth strategy.
The approval makes Rinvoq the who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This positions Rinvoq as a critical new option for patients and a formidable competitor in the immunology market.
This latest regulatory win is crucial for AbbVie as it navigates the highly anticipated revenue decline from its former blockbuster, Humira, which now faces biosimilar competition. Rinvoq, along with its counterpart Skyrizi, is part of a strategic duo AbbVie is counting on to fill the revenue gap and drive a new wave of growth. The two drugs have already captured a significant portion of the inflammatory bowel disease (IBD) market, in Crohn's disease as of mid-2025.
Wall Street has responded positively to the drug's performance and commercial potential. Analysts have noted the favorable efficacy and safety profile, with some specialists calling Rinvoq the 'most promising agent' in its class. The drug's robust sales figures reflect this sentiment, with global net revenues for Rinvoq hitting $2.028 billion in the second quarter of 2025, a 42% year-over-year increase. AbbVie projects the drug will generate around $8 billion in total sales for 2025.
Investor confidence has been further bolstered by recent legal victories. AbbVie successfully settled litigation that extends Rinvoq's patent protection in the U.S. until April 2037, a development that analysts have described as a '. This extended market exclusivity, combined with its expanding list of approved indications, solidifies Rinvoq's long-term value and has helped propel ABBV stock to record highs this year.