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AbbVie Gains FDA Approval for Expanded Rinvoq Use in IBD Patients
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AbbVie Gains FDA Approval for Expanded Rinvoq Use in IBD Patients
Oct 13, 2025 8:50 AM

11:24 AM EDT, 10/13/2025 (MT Newswires) -- AbbVie ( ABBV ) said Monday that the US Food and Drug Administration approved an updated Rinvoq indication for adults with moderately to severely active ulcerative colitis and Crohn's disease.

The updated label permits Rinvoq use before tumor necrosis factor blockers for patients unsuited to TNF inhibitors who have tried at least one approved systemic therapy, the company said.

RINVOQ was previously limited to patients unresponsive or intolerant to TNF blockers.

"This label update provides physicians with greater flexibility to treat patients with moderately to severely active inflammatory bowel disease," said Kori Wallace, AbbVie's ( ABBV ) VP of global immunology clinical development.

The company highlighted Rinvoq's safety risks, including serious infections, cardiovascular events, cancers, blood clots, and allergic reactions, it added.

Shares of the company were up 1% in recent trading.

Price: 232.74, Change: +2.24, Percent Change: +0.97

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