AbbVie Receives Health Canada Approval of HUMIRA® for the Treatment of Pediatric Patients with Moderately to Severely Active Ulcerative Colitis

With this approval, HUMIRA, an anti-TNF monoclonal antibody, provides pediatric patients 5 years of age with moderately to severely active ulcerative colitis (UC) the first subcutaneous anti-TNF treatment option 1 Approval based on central phase 3 results ENVISION I am studying , the largest clinical study in pediatric ulcerative colitis to date showing that HUMIRA produced significant response and remission rates at both week 8 and week 52 1,2

ABBVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved HUMIRA® (adalimumab) to induce and maintain clinical remission in pediatric patients five years of age and older with moderately to severely active colitis ulcerosa (UC) that have responded inadequately to conventional therapy, including corticosteroids and / or azathioprine or 6-mercaptopurine, or are intolerant of such therapies. 1 With this approval, HUMIRA offers pediatric patients with moderately to severely active ulcerative colitis the first subcutaneous anti-TNF therapeutic option. 1

“Ulcerative colitis is a miserable disease when not properly controlled, and it has a significant impact on the lives of children and adolescents. When the disease is active, it is disabling and embarrassing, affecting how children can participate in their normal life with peers and at school. While we can treat many children with ulcerative colitis today, there is still a group of children and adolescents that we cannot help as well as we would like, and so we need access to new therapies, ” said Dr. Anne Griffiths, Co-Lead, Inflammatory Bowel Disease Center at the Hospital for Sick Children.

Ulcerative colitis is characterized by inflammation of the colon with symptoms ranging from mild to severe bowel urge and bowel incontinence as well as weight loss and fatigue. 4,5 It remains a lifelong condition that is not adequately controlled in many patients, underscoring the need for more treatment options. 3,4 Children with ulcerative colitis cannot develop or grow properly due to poor absorption of nutrients by the diseased intestine. Significant unmet needs persist in moderate to severe pediatric ulcerative colitis, compared to adults, as pediatric patients tend to have more extensive disease often causing significant disease in children. 4.6

Cal Spellman, who is now 17, remembers being diagnosed when he was 11 years old. “It was very scary for me. As a child, it can be intimidating when a doctor says you have a chronic illness, and while it is treatable, it can be difficult to deal with. I remember having a really hard time when I was about 12 years old. I was hospitalized twice, four months apart. I had uncontrollable symptoms, which is especially difficult for someone going through puberty when you feel self-conscious about things. But anyone newly diagnosed knows it’s getting better. It will be difficult, but it is something you can handle, and it is possible to live a normal life, ”he explained.

“Canada has one of the highest rates of inflammatory bowel disease (IBD) in the world 5. As the number of cases in children increases, it is important that we continue to expand the number of available pediatric treatment options,” said Susan Cowan, CEO of Crohn’s and Colitis Canada. “Ulcerative colitis, one of the major forms of IBD, is an unpredictable disease that often requires medication to manage debilitating symptoms. The introduction of a new therapy for children with ulcerative colitis is an important step forward. ”

“This approval is an important milestone for children and adolescents living with ulcerative colitis, who often struggle to control this lifelong condition, especially as pediatric patients often have more extensive disease,” added Tracey Ramsay, Vice President and General Manager , AbbVie Canada. “AbbVie is proud of our heritage and commitment to discover and deliver innovative therapies that help adults and children with inflammatory bowel disease.”

About the ENVISION I phase 3 trial 2.7

Health Canada’s approval is based on the results of the ENVISION I trial, a phase 3, randomized, double-blind, multicentre study designed to evaluate the efficacy, safety and pharmacokinetics of HUMIRA in pediatric patients (ages 4-17) with moderate to severe ulcerative colitis, administered subcutaneously.

The ENVISION I study showed that HUMIRA achieved the co-primary endpoints of clinical remission at week 8 and, of those who responded at week 8, clinical remission at one year (52 weeks). 1.2

No new safety signals for HUMIRA were observed in this study. 1,2 In patients exposed to HUMIRA during the study, 23 percent experienced a serious adverse reaction. 1,2 The most frequently reported (greater than or equal to five percent) treatment-emergent adverse reactions during induction and maintenance periods were headache and ulcerative colitis. 1,2 No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study. 1.2

More information about this trial can be found at www.clinicaltrials.gov (NCT02065557).

About HUMIRA

HUMIRA is similar to antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

For more information, see the HUMIRA product monograph available at www.abbvie.ca.

About AbbVie in Gastroenterology

AbbVie has been focused on improving care in gastroenterology for over 10 years. With a robust clinical trial program for inflammatory bowel disease (IBD), we are committed to cutting-edge research to drive exciting discoveries and developments in Crohn’s disease and ulcerative colitis. By innovating, learning and adapting, AbbVie strives to eliminate the burden of IBD and have a long-lasting impact on the lives of people with IBD.

About AbbVie

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

References:

HUMIRA (adalimumab) Product monograph. AbbVie Corporation. Available at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/HUMIRA_PM_EN.pdf. Accessed April 21, 2021. Croft NM, et al. Efficacy and safety of adalimumab in pediatric patients with moderate to severe ulcerative colitis: results of a phase 3 randomized controlled trial. UEGJ. 2020; 8 (8S): 98-99. The economic costs of Crohn’s disease and ulcerative colitis. Access to Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf. Romano, C., et al., Management of Acute Severe Colitis in Pediatric Ulcerative Colitis in the Biological Age. Pediatrics. 2016; 137 (5): e20151184. Crohn’s and Colitis Canada. Inflammatory Bowel Disease Impact Report 2018. Available at: https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf. Access until March 29, 2020. Jakobsen C., et al. Differences in phenotype and disease course in adult and pediatric inflammatory bowel disease – a population-based study. Aliment Pharmacol Ther. 2011; 34 (10): 1217-1224 pmid: 21981762. Efficacy and safety of adalimumab in pediatric subjects with moderate to severe ulcerative colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02065557. Accessed October 6, 2020.

SOURCE AbbVie Canada

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