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Press release from CNW Group

Health Canada Approves HUMIRA® (adalimumab) for the Treatment of Ulcerative Colitis (UC)

Thursday, November 28, 2013

Health Canada Approves HUMIRA® (adalimumab) for the Treatment of Ulcerative Colitis (UC)

07:55 EST Thursday, November 28, 2013

Approval marks eighth indication in Canada for HUMIRA®

MONTREAL, Nov. 28, 2013 /CNW/ - AbbVie announced today that Health Canada has approved HUMIRA® (adalimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP) or who are intolerant to such therapies. The efficacy of HUMIRA® in patients who have lost response to or were intolerant to TNF blockers has not been established.

With this eighth indication, HUMIRA® is now approved for the treatment of the two primary diseases that comprise inflammatory bowel disease (IBD): Crohn's disease and ulcerative colitis.

"For gastroenterologists, having another treatment in our arsenal to treat ulcerative colitis is a huge win.  Practicing gastroenterologists are very comfortable with using HUMIRA®,which was the first subcutaneous biologic approved for use in inflammatory bowel disease when it was approved for Crohn's disease in 2007. When left untreated, UC may lead to quality of life issues, life-threatening complications, and lead to major surgery with removal of the entire large intestine. It is paramount to diagnosis early and treat this disease optimally," explains Dr. Remo Panaccione, Professor, Department of Medicine, University of Calgary, Director, Inflammatory Bowel Disease Clinic.  "Since 20 to 30 per cent of people with IBD are diagnosed before the age of 20, our primary goal is to set these people on the path to remission and ensure they can live their lives to the fullest."

Ulcerative colitis is a chronic disease of the colon, marked by inflammation and ulceration of the colon mucosa, or innermost lining1. According to the Crohn's and Colitis Foundation of Canada's The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and Recommendations, Canada has among the highest reported prevalence and incidence of IBD in the world. There are approximately 233,000 Canadians living with IBD, and 104,000 of them live with UC. Approximately 4,500 new cases of UC are diagnosed every year1.

"The Crohn's and Colitis Foundation of Canada is committed to finding cures for ulcerative colitis and Crohn's disease," states CCFC Chief Executive Officer, Dr. Kevin Glasgow. "While we work on finding cures, we are committed to improving the lives of children and adults affected by inflammatory bowel disease.  IBD treatments approved by Health Canada will increase access, provide more treatment options, and improve the quality of life for Canadians living with ulcerative colitis."

Canadians prescribed HUMIRA® for UC will have the opportunity to be enrolled in PROGRESS, the HUMIRA® support program, which provides a wide range of services including insurance, injection, education and ongoing support.

"The approval of HUMIRA® for ulcerative colitis is a testament to the growing need for targeted treatments in Canada," says Felipe Pastrana, General Manager, AbbVie Canada. "With HUMIRA® and with initiatives such as the AbbVie IBD Scholarship Program, we want to empower people living with IBD and provide them with all the right tools to succeed."

HUMIRA® is also approved in Canada in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), and psoriasis (Ps), as well as in children aged 4 to 17 years for the treatment of polyarticular juvenile idiopathic arthritis (JIA) and in pediatric patients with Crohn's disease (CD) 13 to 17 of age, ≥40kg.

   
1 The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and Recommendations, Crohn's and Colitis Foundation of Canada. http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf

About HUMIRA ®

HUMIRA® resembles 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.

HUMIRA® is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA® spans 15 years across multiple indications, including 71 clinical trials with over 23,000 patients. HUMIRA® is approved in 90 countries and used by over 670,000 patients worldwide.

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA® can cause serious side effects2. Before initiation of, during and after treatment with HUMIRA®, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA® Product Monograph2 available at www.abbvie.ca.

Important Safety Information2
HUMIRA® is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections. Serious infections have happened in people taking HUMIRA ® . These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA® use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA® should not be started in a person with an active infection, unless approved by a doctor. HUMIRA® should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA®, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA®, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life threatening if treated.

Other possible serious side effects with HUMIRA® include hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions, including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis. The use of HUMIRA® with other biologic DMARDS (e.g., anakinra, or abatacept), or other TNF antagonists is not recommended. People using HUMIRA® should not receive live vaccines.

Common side effects of HUMIRA® include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA® is given by injection under the skin. The benefits and risks of HUMIRA® should be carefully considered before starting therapy.

This is not a complete list of the Important Safety Information for HUMIRA®. For additional important safety information, please consult the HUMIRA® Product Monograph2 at: www.abbvie.ca

   
2 HUMIRA® (adalimumab) Product Monograph. Date of Revision: November 21, 2013

About AbbVie
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and structure of a long-established pharmaceutical leader. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie aims to help patients live healthier lives and collaborate on sustainable healthcare solutions. AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com or www.abbvie.ca. Follow @AbbVienews on Twitter or check out careers on our Facebook page.

 

SOURCE AbbVie

For further information:

Media inquiries
Muriel Haraoui
AbbVie
514-717-3764
muriel.haraoui@abbvie.com 

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Ashleigh Cartier
Media Profile
416-342-1826
ashleigh.cartier@mediaprofile.com

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