AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) updating the indication statement for RINVOQ (upadacitinib) in the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease (CD).

Previously, RINVOQ was approved for adults with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. With this updated indication, healthcare providers may now prescribe RINVOQ for patients who have received at least one approved systemic therapy when the use of TNF blockers is considered clinically inadvisable.

“At AbbVie, we remain deeply committed to addressing the evolving needs of people living with inflammatory bowel disease,” said Kori Wallace, M.D., Ph.D., vice president and global head of immunology clinical development at AbbVie. “Ulcerative colitis and Crohn’s disease can profoundly affect every aspect of a patient’s life. This label update provides physicians with greater flexibility to tailor treatment approaches, enabling the use of RINVOQ for appropriate patients earlier in their care journey when TNF blockers are not suitable.”

AbbVie continues to advance its mission to improve care and expand therapeutic options for patients living with immune-mediated diseases such as ulcerative colitis and Crohn’s disease.