FDA Grants Rinvoq Updated Indication in IBD

The FDA approved a supplemental new drug application for the JAK inhibitor upadacitinib (Rinvoq, AbbVie) permitting its use in the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

The updated indication allows for starting upadacitinib before a TNF blocker in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy, the company said in a statement. 

Previously, upadacitinib was indicated only in adults with moderately to severely active ulcerative colitis or Crohn’s disease who had an inadequate response or intolerance to one or more TNF blockers. 

“Ulcerative colitis and Crohn’s disease can impact every aspect of a patient’s life. This label update gives healthcare providers the option to prescribe Rinvoq 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,” Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in the statement. 

Full prescribing information is available online. 

Wallace is an employee of AbbVie.

A version of this article appeared on Medscape.com .