FDA Approves SKYRIZI® for Ulcerative Colitis, Expanding AbbVie’s IBD Portfolio

FDA Approves SKYRIZI® for Ulcerative Colitis, Expanding AbbVie’s IBD Portfolio

AbbVie announced that the U.S. FDA has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This marks SKYRIZI as the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and Crohn’s disease. SKYRIZI is now approved for four immune-mediated inflammatory diseases.

“Early and sustained clinical remission and endoscopic improvement are crucial for treating ulcerative colitis,” said Dr. Edward V. Loftus, Jr., Mayo Clinic. “This approval for SKYRIZI is a significant step toward these treatment goals.”

Over 1 million Americans live with ulcerative colitis, an inflammatory bowel disease (IBD) that affects the digestive tract and can damage the colon lining. Symptoms include abdominal pain, bloody stool, and urgency to use the bathroom, varying widely among patients and potentially leading to surgery or complications, including cancer or death.

“Today’s approval expands our IBD portfolio and underscores our commitment to addressing patient needs,” said Dr. Roopal Thakkar, AbbVie. “We will continue to invest in transforming the treatment landscape for IBD sufferers.”

SKYRIZI dosing includes a 12-week induction period with three 1200 mg doses every four weeks, followed by maintenance therapy of either 180 mg or 360 mg every eight weeks. Post-induction, SKYRIZI can be administered at home using a hands-free on-body injector (OBI) that delivers the medication in about five minutes.

Patients should avoid SKYRIZI if allergic to it. Potential side effects include serious allergic reactions, increased infection risk, and liver problems. Before starting treatment, doctors should check for infections and tuberculosis and monitor liver health.

SKYRIZI, developed in collaboration with Boehringer Ingelheim and AbbVie, is available globally. AbbVie offers patient support programs to reduce out-of-pocket costs and provides assistance through myAbbVie Assist for those with limited or no insurance.

For more information about SKYRIZI, visit SKYRIZI.com.

About Ulcerative Colitis

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine, causing continuous mucosal inflammation. Symptoms include rectal bleeding, abdominal pain, bloody diarrhea, urgency, and fecal incontinence. The disease course varies, potentially leading to substantial burden, disability, and complications, including surgery, cancer, or death.

Clinical Studies

INSPIRE Induction Study: A Phase 3 study evaluating risankizumab 1200 mg IV for moderately to severely active ulcerative colitis. The primary endpoint is clinical remission at week 12. More details: www.clinicaltrials.gov (NCT03398148).

COMMAND Maintenance Study: A Phase 3 study assessing risankizumab 180 mg or 360 mg SC for maintenance therapy in adults with moderately to severely active ulcerative colitis. The primary endpoint is clinical remission at week 52. More details: www.clinicaltrials.gov (NCT03398135).

About SKYRIZI® (risankizumab-rzaa)

SKYRIZI is an IL-23 inhibitor blocking IL-23’s p19 subunit, involved in inflammatory processes linked to chronic immune-mediated diseases. Approved for ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

For full prescribing information and safety details, visit SKYRIZI.com.

Patient Access & Support

AbbVie offers programs to help patients access SKYRIZI, including co-pay cards and patient assistance through myAbbVie Assist. More details at www.AbbVie.com/myAbbVieAssist.

For more information about side effects, dosing, and safety, visit the FDA’s MedWatch or call 1-800-FDA-1088.

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