Improving DxMultiomics, Powered by Your Choices

We're building DxMultiomics to be The Central Nexus of Biotech Intelligence. To ensure a seamless experience and continuous improvement, we utilize website analytics. These tools help us monitor site performance, understand how users navigate the platform, and identify opportunities to make your research journey more efficient. We handle this data with the utmost respect for your privacy, and you can choose what works best for you.

FDA Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease
_↗ news.abbvie.com
News Image

The U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) to update the indication statement for RINVOQ® (upadacitinib), a JAK inhibitor used to treat inflammatory bowel disease (IBD), according to an announcement from AbbVie

The updated indication expands the patient population eligible for the drug, specifically for adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Previously, RINVOQ was only indicated for patients who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The revised indication now also allows for the use of RINVOQ in patients who have received at least one approved systemic therapy, in cases where the prescribing physician determines that the use of TNF blockers is clinically inadvisable. This label update offers healthcare providers greater flexibility in prescribing the medicine to patients suffering from IBD, which is characterized by chronic, unpredictable inflammation of the gastrointestinal tract.

However, the safety considerations for RINVOQ remain significant. The drug carries a Boxed Warning for serious side effects, including an increased risk of serious infections (some fatal, including tuberculosis), cancer and immune system problems (including lymphoma and skin cancer, with higher risk for smokers), major cardiovascular (CV) events (such as heart attack, stroke, or death in people age 50 and older with at least one heart disease risk factor), and blood clots (in the legs, lungs, and arteries). Patients are also warned about the potential for serious allergic reactions and tears in the stomach or intestines. Due to these risks, healthcare providers must conduct thorough screenings for infections, monitor patients for signs of CV events and cancer, and perform regular laboratory blood tests. AbbVie provides patient access and support programs, including a co-pay card and the myAbbVieAssist Patient Assistance Program, to help eligible patients afford the medication. Developed by AbbVie scientists, RINVOQ is a cornerstone of the company's commitment to gastroenterology research, with ongoing Phase 3 trials exploring its use in several other immune-mediated inflammatory diseases.

Log In
Sign Up