Abbvie gets USFDA approval for updated indication statement for Rinvoq for Inflammatory Bowel Disease
North Chicago: AbbVie has received the U.S. Food and Drug Administration (FDA) approval for a supplemental new drug application (sNDA) that updates the indication statement for RINVOQ (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD).
Previously, RINVOQ was indicated 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. The updated indication statement also allows the use of RINVOQ for patients after they have received at least one approved systemic therapy in the event TNF blockers are clinically inadvisable.
"At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "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."
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.
Inflammatory bowel disease (IBD) is a group of diseases characterized by chronic inflammation of the gastrointestinal (GI) tract. Crohn's disease (CD) and ulcerative colitis (UC) are the most common forms of IBD. In both CD and UC, the immune system causes inflammation and damage to the mucosa – or lining – of the gut. Specifically, CD manifests as inflammation within the GI tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain. UC is a chronic, idiopathic, immune-mediated IBD of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon. The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence. CD and UC are progressive diseases, meaning they get worse over time and may lead to life-threatening complications or surgery. Because the signs and symptoms of CD and UC are unpredictable, they cause a significant burden on people living with the disease—not only physically, but also emotionally and economically.
