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.
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. 1-2,4 The 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. 8About HUMIRA in the European Union6HUMIRA EU Therapeutic IndicationsHUMIRA 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)