AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

- Significantly more upadacitinib patients achieved the primary and all secondary endpoints compared to placebo in Phase 3 induction and maintenance studies supporting the submissions[1-3]

- Safety results were generally consistent with the known safety profile of upadacitinib, with no new important safety risks observed[1-7]

- Upadacitinib has safety data supported by clinical programs evaluating more than 14,000 patients. It has been approved in rheumatoid arthritis (US/EU), psoriatic arthritis (EU), ankylosing spondylitis (EU) and atopic dermatitis (EU)[8-14]

NORTH CHICAGO, IL, USA I September 16, 2021 I AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

"Many people continue to struggle with symptoms associated with their ulcerative colitis, such as fatigue, bowel urgency, bloody diarrhea and abdominal pain," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "Upadacitinib has the potential to be an important new treatment option for people with ulcerative colitis, who want to address these challenging and disruptive symptoms. We look forward to working with regulatory authorities and hope to bring upadacitinib to people with ulcerative colitis as quickly as possible."

The applications are supported by data from two Phase 3 induction studies and one maintenance study.1-3 In these studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints compared to placebo with 45 mg once daily at week 8 for the induction studies, and with 15 mg and 30 mg once daily at 52 weeks for the maintenance study.1-3

The safety results of upadacitinib, including the 45 mg dose as induction therapy, in these studies were generally consistent with the known safety profile of upadacitinib, with no new important safety risks observed.1-7

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.15,16 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.15,17 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.16,19 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.18

About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies1-3,14-16
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in subjects with moderate to severe ulcerative colitis. Topline results of the U-ACHIEVE induction study were announced in December 2020, topline results of the second induction study, U-ACCOMPLISH, were announced in February 2021, and topline results of the U-ACHIEVE maintenance study were announced in June 2021. More information can be found on www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).

About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-3,14-22 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.30 RINVOQ 15 mg is approved in the U.S. for adults with moderately to severely active rheumatoid arthritis. RINVOQ 15 mg also is approved in the EU for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and adults and adolescents 12 years and older with moderate to severe atopic dermatitis (AD). RINVOQ 30 mg is approved in the EU for adults with moderate to severe AD under age 65. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondylarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.21-29 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

Please see the full SmPC for complete prescribing information at www.EMA.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, FacebookLinkedIn or Instagram.

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SOURCE: AbbVie

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