An anti-inflammatory drug that AbbVie has been developing as a successor to adalimumab (Humira), the world’s top-selling drug, won the regulatory OK Friday as a treatment for rheumatoid arthritis (RA).
The FDA approved upadacitinib (Rinvoq) for adults with RA whose disease hasn’t responded to other treatments. About 1.3 million people in the US have the autoimmune disorder, which causes joint pain and can lead to permanent damage to bone and cartilage.
The North Chicago, IL-based pharma company tested upadacitinib in about 4,400 patients across five studies. The anti-inflammatory drug, a daily pill, in head-to-head tests outperformed Humira, an injectable drug that is facing generic competition.
In the trials, the most common side effects of upadacitinib were upper respiratory tract infections, nausea, cough, and fever.
Part of a new class of RA drugs called JAK inhibitors, the AbbVie drug comes with a safety warning that indicates the potential for more serious health problems, including infections and blood clots. The FDA recently added a black box warning to the label of Pfizer (NYSE: PFE) drug Xeljanz, a JAK inhibitor approved for RA in 2012, indicating the potential for deadly blood clots at higher doses. The higher dose of that drug is only approved as a treatment for ulcerative colitis, however.
The FDA approved Eli Lilly JAK inhibitor, baricitinib (Olumiant), last year for RA. The once-daily pill also carries a black box warning on its label.
AbbVie says it expects to launch its RA drug later this month. The company didn’t immediately respond to a request for pricing information. Xconomy will update this story with the information once it does.