FDA approves expanded use for Rinvoq

The US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, US pharma major AbbVie (NYSE: ABBV) announced yesterday

This FDA approval is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from three Phase III randomized, double-blind, placebo-controlled clinical studies. In its existing indications that include rheumatoid arthritis and atopic dermatitis, JAK inhibitor Rinvoq pulled in 2021 sales of $1.65 billion, up more than 100% on the prior year, and AbbVie has previously said it expects the drug to achieve revenues of $7.5 billion.

"There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome," said Dr Thomas Hudson, senior vice president of R&D, and chief scientific officer, AbbVie. "With the approval of Rinvoq as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis," he noted.