AbbVie's HUMIRA® (Adalimumab) Receives CHMP Positive Opinion to Treat Adolescents with Hidradenitis Suppurativa, a Chronic Inflammatory Skin Disease

- If approved by the European Commission, HUMIRA will be the first and only treatment option for patients aged 12 and older with hidradenitis suppurativa (HS), a painful, chronic inflammatory skin disease.

- Hidradenitis suppurativa is estimated to affect 1 - 4 percent of the world's population.[1-2]

News provided by

AbbVie

Nov 14, 2016, 03:00 ET

NORTH CHICAGO, Ill., Nov. 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the 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 active moderate to severe hidradenitis suppurativa (HS) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. If approved, HUMIRA will become the first and only biologic treatment option for patients 12 years of age and older. HUMIRA was approved for adults with moderate to severe HS by the European Commission in July 2015.

"Hidradenitis suppurativa can start at puberty and become worse over time. It is important for patients to receive an early and accurate diagnosis and treatment to better manage the life course effects of the disease," said John Medich, Vice President, Immunology Clinical Development, AbbVie. "This positive CHMP opinion is a significant milestone for patients impacted by this painful, chronic disease as there are currently no approved medications available for adolescents to treat it."

Hidradenitis suppurativa, sometimes referred to as "acne inversa" by dermatologists, is a painful, debilitating, chronic inflammatory skin disease estimated to affect 1 – 4 percent of the world's population.^1-2 The prevalence of HS among adolescents between the ages of 12 and 17 years is estimated to be 0.09 percent (298 adolescents diagnosed with HS out of 328,634 total adolescents sampled).³ The condition is characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.^1-2 HS can have considerable impact on patients' quality of life, physical activities and emotional state.^1-2,4The disease can be challenging to diagnose, with studies showing it can take up to eight years for people with HS to receive an accurate diagnosis.^1-2,5

Since first gaining approval 13 years ago, HUMIRA has been approved in more than 90 countries across 14 globally approved indications,^6-7 and is currently being used to treat more than a million patients worldwide.⁸

About HUMIRA in the European Union⁶

HUMIRA EU Therapeutic Indications
HUMIRA is approved for use in adults with moderate to severe active and progressive 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, active moderate to severe hidradenitis suppurativa and non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indication.

Important EU Safety Information⁶HUMIRA 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," of AbbVie's 2015 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.

References:

Dufour DN, Emtestam L, Jemec GB. Hidradenitis suppurativa: a common and burdensome, yet under-recognised, inflammatory skin disease. Postgrad Med J. 2014; 90:216-221.
Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
European Medicines Agency decision P/0121/2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500144686.pdf. Accessed October 31, 2016.
Esmann S, Jemec GB. Psychosocial impact of hidradenitis suppurativa: a qualitative study. Acta dermato-venereologica. 2011; 91(3):328-332.
Guiding principles in Hidradenitis Suppurativa (HS) care. KPMG. Accessed October 31, 2016.
HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://ec.europa.eu/health/documents/community-register/2016/20160624135201/anx_135201_en.pdf. Last updated Jun 24, 2016. Accessed October 31, 2016.
Pharmaceutical and Medical Devices Agency (PMDA). New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed October 31, 2016.
Data on File, AbbVie Inc. IMS NPA and IMS NSP cumulative data as of June 2016.