– Marketing Authorization Decision Expected from the European Commission in the Second Quarter –
NORTH CHICAGO, Illinois, Feb. 27, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age. If granted marketing authorization by the European Commission, HUMIRA may become the first treatment available for 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.
"The positive response from the CHMP marks an important step in addressing the needs of children and adolescents living with severe plaque psoriasis in Europe," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Building on more than 16 years of clinical experience with HUMIRA, we look forward to the opportunity to make a positive impact on the lives of pediatric plaque psoriasis patients."
The positive opinion is based on the results of a Phase 3 study, which will be presented at an upcoming medical meeting. The review of the marketing authorization application (MAA) 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 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 843,000 patients worldwide1 across 10 globally approved indications.2
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, active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy, 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. 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 https://www.medicines.org.uk/emc/medicine/21201)
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.
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, 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.
- AbbVie Data on File.
- HUMIRA Summary of Product Characteristics. Updated November 2014. Available at: https://www.medicines.org.uk/emc/medicine/21201. Accessed February 19 2015.
- 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 February 10 2015.
- 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 February 10 2015.
- Psoriasis Fact Sheet. National Institutes of Health. 2010. Available at: http://www.report.nih.gov/nihfactsheets/Pdfs/Psoriasis%28NIAMS%29.pdf. Accessed February 12 2015.
- 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.