The FDA has updated the indication of the Janus kinase inhibitor upadacitinib (Rinvoq, AbbVie) for the treatment of adults with moderate to severe inflammatory bowel disease, according to a news release, potentially expanding the eligible treatment population.
The former indications, in place since the drug’s approval for ulcerative in 2022 and Crohn’s disease in 2023, allowed for its use in the second line after intolerance or inadequate response to a tumor necrosis factor inhibitor, but now has been expanded to include patients who fail any systemic therapy in the event they cannot take a TNF blocker for clinical reasons.
“This label update gives healthcare providers the option to prescribe [upadacitinib] for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician,” wrote Kori Wallace, MD, PhD, vice president of AbbVie in a press release.
—GEN Staff