AbbVie announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease. SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases. With over 1 million people living with ulcerative colitis, the United States has one of the largest populations affected by this disease and the numbers are continuing to rise.

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom. The disease course of ulcerative colitis varies between patients, and in some cases can lead to surgery or complications, including cancer or death.

Dosing of SKYRIZI for this indication includes a 12-week induction period with three 1200 mg doses delivered every four weeks, followed by maintenance therapy of either 180 mg or 360 mg delivered every eight weeks. Following the induction period, SKYRIZI treatment can be maintained at home using an on-body injector (OBI). The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about five minutes to deliver the medication following preparation steps.

AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. Financial support might also include reimbursement for out-of-pocket costs related to IV administration. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify.

More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist. About Ulcerative Colitis: Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (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 ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.

The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death. The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease. SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.10 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.11 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease.

SKYRIZI is a prescription medicine used to treat adults with: moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis. moderate to severe Crohn's disease.

moderate to severe ulcerative colitis. Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if get any of the following symptoms of a serious allergic reaction: ? fainting, dizziness, feeling lightheaded (low blood pressure) ?

swelling of face, eyelids, lips, mouth, tongue, or throat ? trouble breathing or throat tightness ? chest tightness ?

skin rash, hives ? itching Infections. Do not use SKYRIZI if allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.