AbbVie Receives CHMP Positive Opinion for HUMIRA® (adalimumab) for the Treatment of Pediatric Patients, from Six Years of Age, with Moderately to Severely Active Crohn's Disease

NORTH CHICAGO, Ill., April 4, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of moderately to severely active Crohn's disease in pediatric patients (from six years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

HUMIRA is currently approved in the European Union for the treatment of severe active Crohn's disease in pediatric patients (from six years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.²

"The positive CHMP opinion represents a significant milestone for the pediatric gastroenterology community as we move closer to European approval of HUMIRA in pediatric patients with moderately to severely active Crohn's disease, a chronic condition with no known cure that affects a growing number of children worldwide," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to the ongoing study and innovation of HUMIRA, and we look forward to expanding this treatment option, once approved, to help more children with this debilitating illness during a vulnerable time in their lives."

"There is no known cure for children and adolescents affected by Crohn's disease, therefore treatment options are important," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "A large-scale investigation such as the IMAgINE trial showcases the safety and efficacy profile of HUMIRA in the moderately to severely active pediatric Crohn's disease population."

Pediatric Crohn's disease is characterized by periods in which the disease flares up, is active and causes symptoms.^1,3 These episodes can be followed by times of remission—periods in which symptoms disappear or decrease.^1,3 In addition to signs and symptoms such as abdominal pain, weight loss and diarrhea, pediatric Crohn's disease can affect children in several ways unique to this age group, including delayed growth and/or puberty.¹

The positive opinion is based on the results of the IMAgINE-1 study, the largest multi-center, randomized, open-label induction, followed by double-blind maintenance trial in patients six to 17 years of age with moderately to severely active Crohn's disease to date.^4,5 Moderately to severely active Crohn's disease was defined by a Pediatric Crohn's Disease Activity Index (PCDAI) > 30 at baseline.⁵

The study found that 63 patients (33.5 percent) were in clinical remission at week 26 and a greater proportion of patients in the standard-dose HUMIRA group (36/93) achieved clinical remission compared to the low-dose HUMIRA group (27/95; P=0.075). Clinical remission was defined as a PCDAI score of less than 10. At week 52, the proportion of patients in clinical remission in the HUMIRA standard-dose group (31/93) was greater compared with the low-dose HUMIRA group (22/95; P=0.100).⁵

In the study, HUMIRA therapy was initiated with a 4-week induction period consisting of 80 mg and 40 mg administered subcutaneously at weeks 0 and 2, respectively, for patients with bodyweight <40 kg or 160 mg and 80 mg at weeks 0 and 2, respectively, for patients with bodyweight >40 kg. Following the induction period, 188 patients were randomized 1:1 to standard-dose or low-dose double-blind HUMIRA treatment (standard-dose: 20 mg every other week for patients with bodyweight <40 kg or 40 mg every other week for patients with bodyweight >40 kg; low-dose: 10 mg every other week for patients with bodyweight <40 kg or 20 mg every other week for patients with bodyweight >40 kg).⁵

The review of the variation to the Marketing Authorization (MA) is being conducted under the centralized licensing procedure. If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

Since first gaining approval more than 13 years ago for rheumatoid arthritis, HUMIRA has been approved in more than 90 countries and is currently being used to treat more than 955,000 patients worldwide⁶ across 13 globally approved indications.^2,7

About HUMIRA in the European Union  

HUMIRA EU Therapeutic Indications²

HUMIRA is approved for use in adults with moderate to severe active rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and active moderate to severe hidradenitis suppurativa. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, severe active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indication.

Important EU Safety Information²

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

(See SmPC for full details)

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

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. 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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 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. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1. Kelsen J, Baldassano RN. Inflammatory bowel disease: the difference between children and adults. Inflamm Bowel Dis. 2008;14 Suppl 2:S9-S11. doi:10.1002/ibd.20560.
2. HUMIRA [Summary of Product Characteristics]. AbbVie Ltd. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated January 28, 2016. Accessed March 23, 2016.
3. Gouldthorpe O, Catto-Smith AG, Alex G. Biologics in paediatric Crohn's disease. Gastroenterol Res Pract. 2011;2011:1-10. doi:10.1155/2011/287574.
4. National Library of Medicine (NLM) at the Institutes of Health (NIH) website. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/results/displayOpt?flds=a&flds=b&flds=g&submit_fld_opt=on&term=TNF%2C+pediatric&cond=crohn%27s+disease&phase=2&show_flds=Y. Accessed March 23, 2016.
5. Hyams JS, Griffiths A, Markowitz J, et al. Safety and efficacy of adalimumab for moderate to severe Crohn's disease in children. Gastroenterology. 2012;143(2):365-374.e2. doi:10.1053/j.gastro.2012.04.046.
6. Data on File ABVRRTI61976.
7. Pharmaceutical and Medical Devices Agency (PMDA) website. New Drugs Approved in FY 2013. http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed February 17, 2016.

SOURCE AbbVie

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