New Treatment Option Available for Canadian Children Living with Severely Active Pediatric Crohn's Disease

AbbVie's HUMIRA^® is the First Subcutaneous Biologic Approved in Canada for the Treatment of Pediatric Crohn's

MONTREAL, Aug. 27, 2013 /CNW/ - AbbVie announced today that Health Canada has approved HUMIRA^® (adalimumab) for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40 kg with severely active Crohn's disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist.

With this approval, HUMIRA^® becomes the first biologic treatment in the form of a subcutaneous injection approved for these patients. Furthermore, it is HUMIRA^®'s second approval in the field of inflammatory bowel disease (IBD) after adult Crohn's disease, and the seventh approval for the treatment of immune mediated inflammatory diseases in Canada.

Pediatric Crohn's disease, a chronic, debilitating condition of the gastrointestinal (GI) tract, is a type of IBD that most commonly involves the end of the small intestine and the beginning of the large intestine. An estimated 5,900 Canadian children have IBD. In fact, Canada has one of the highest rates of childhood-onset of IBD in the world and the incidence of IBD has been rising, particularly since 2001, and significantly so in children under the age of 10¹. According to the Crohn's and Colitis Foundation of Canada's The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and Recommendations, 20 to 30% of people with IBD are diagnosed before the age of 20¹.

"For parents like myself that have a child living with pediatric Crohn's, it's a huge relief to know that there is now a new treatment approved and available here in Canada," said Kate Murray, Executive Director of Robbie's Rainbow, a registered children's charity dedicated to improving the health and quality of life of children living with Crohn's disease and Ulcerative Colitis. "This will be a convenient new option for children living with the disease, as well as their families, as it empowers them to take a more active role in the treatment and management of their disease."

To help both parents and teens take an active role in managing the disease, a free mobile app myIBD was developed by nurses, doctors and patients at SickKids Hospital in Toronto, and supported by AbbVie. "myIBD app is an empowerment tool. It allows patients along with their families to properly track the evolution of the disease and therefore anticipate any potential flare-up," said Karen Frost, IBD Nurse Practitioner, Division of Gastroenterology, Hepatology and Nutrition, SickKids Hospital. "Since the launch of this app, I now see my patients being more involved in the management of their disease and therefore have better health outcomes. This tool also prepares them for adulthood when they will have to manage their disease along with all of their other responsibilities."

The myIBD app allows patients to track their food intake, stool consistency, pain, and frequency of washroom visits, all on their mobile device. It then compiles the information into a number of graphs, which helps patients track how they have been feeling over time. This regular documentation provides valuable insight to physicians.

The recommended HUMIRA^® induction dose regimen for pediatric patients with severely active Crohn's disease and moderately active Crohn's disease with no response to conventional therapy is 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) followed by 80 mg at Week 2 (given as two 40 mg injections in one day). The recommended HUMIRA^® maintenance dose regimen is 20 mg every other week beginning at Week 4. For pediatric patients who experience a disease flare or non-response, dose escalation to 40 mg every other week may be considered.

"The availability of HUMIRA^® for patients with Pediatric Crohn's addresses a need throughout Canada and underscores our long-standing commitment to patients with IBD," said Felipe Pastrana, General Manager, AbbVie Canada. "HUMIRA^® helps empower patients and their families by offering the flexibility and freedom to get their treatment in the comfort of their own home, according to their doctor's recommendations."

The use of HUMIRA^® in pediatric patients with Crohn's disease ages 13 to 17 has been evaluated up to one year in clinical studies.

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), and in children aged 4 to 17 years for the treatment of polyarticular juvenile idiopathic arthritis (JIA).

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 89 countries and used by over 670,000 patients worldwide.

Any medicines can have side effects. Like all medicines that affect your immune system, HUMIRA^® can cause serious side effects². Before initiation of, during and after treatment with HUMIRA^®, patients should be evaluated for active or latent 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. 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 anakinra or abatacept 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

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