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AbbVie's HUMIRA® (Adalimumab) Approved by European Commission to Treat Children and Adolescents with Severe Chronic Plaque Psoriasis

Nachrichtenquelle: PR Newswire (engl.)
01.04.2015, 16:23  |  890   |   |   

– HUMIRA is the only Biologic Approved in Europe for Children and Adolescents from Four Years of Age with Severe Chronic Plaque Psoriasis –

NORTH CHICAGO, Illinois, April 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has granted marketing authorization for HUMIRA® (adalimumab) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. With the EC decision, HUMIRA now has approval for use in this indication in all member states of the European Union.

"Several treatments have been shown to be effective in subgroups of patients with pediatric psoriasis. However, a limited body of supporting data is available. The approval of adalimumab is an important milestone in particular for children with severe disease because it extends the armamentarium of the physicians who are working to reduce the burden of this chronic disease in this sensitive young patient population," said Marieke M.B. Seyger, MD, PhD, Associate Professor of Dermatology, Radboud University Medical Center in Nijmegen, Netherlands.

The marketing authorization is based on the positive results of a Phase 3 study, which will be presented at an upcoming medical meeting. Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 851,083 patients worldwide1 across 11 globally approved indications.2

"With the approval from the European Commission, HUMIRA is now the only biologic approved in Europe to treat children with this condition starting at four years of age, offering an important new option for physicians treating pediatric plaque psoriasis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This new indication contributes to the increasingly broad spectrum of indications for HUMIRA, and supports its strong record of efficacy and safety in treating pediatric populations who are managing challenging chronic diseases."

About Pediatric Chronic Plaque Psoriasis
According to estimates from the World Health Organization, pediatric psoriasis occurs in 0.70 percent of the pediatric population,3 with no significant difference by gender.4 The chronic autoimmune disease is characterized by the rapid and excessive accumulation of skin cells, which form thick patches of inflamed, scaly skin.5 Pediatric psoriasis has similar characteristics to adult psoriasis, but in children, the psoriatic lesions are typically smaller, thinner, and less scaly.4 Beyond the physical challenges of managing the chronic skin disorder, it is also considered to have significant emotional and psychological effects.6

HUMIRA EU Therapeutic Indications2  
HUMIRA is approved for use in moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's Disease and moderate to severely active ulcerative colitis. HUMIRA is approved in pediatric patients for use in enthesitis-related arthritis, severe plaque psoriasis, severe Crohn's disease, and active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy. See SmPC for full indication.

Important EU Safety Information2
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure. 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 a TNF-antagonist. 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, abdominal pain, nausea, rash and musculoskeletal pain.

(see SmPC for full details at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124)

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. AbbVie employs more than 26,000 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.

AbbVie Data on File.

2.

HUMIRA Summary of Product Characteristics. Updated March 2015. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Accessed March 30, 2015.

3.

Psoriasis. Report by the Secretariat. World Health Organization. 5 April 2013. Available at: http://apps.who.int/gb/ebwha/pdf_files/EB133/B133_5-en.pdf. Accessed March 30, 2015.

4.

Fotiadou C, Lazaridou E, Ioannides D. Management of psoriasis in adolescence. Adolesc Health Med Ther. 2014; 5: 25-34. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3961070/. Accessed March 30, 2015.

5.

Psoriasis Fact Sheet. National Institutes of Health. 2010. Available at: http://www.report.nih.gov/nihfactsheets/Pdfs/Psoriasis%28NIAMS%29.pdf. Accessed March 30, 2015.

6.

Seyhan M, Coskun B.K., Saglam H, Ozcan H, Karincaoglu Y. Psoriasis in childhood and adolescence: evaluation of demographic and clinical features. Pediatrics International. 2006; 48: 525–530.

Wertpapier: AbbVie

Themen: Euro, Twitter, Som


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AbbVie's HUMIRA® (Adalimumab) Approved by European Commission to Treat Children and Adolescents with Severe Chronic Plaque Psoriasis

– HUMIRA is the only Biologic Approved in Europe for Children and Adolescents from Four Years of Age with Severe Chronic Plaque Psoriasis –

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