- Marketing Authorization Decision Expected from the European Commission in the Third Quarter of 2015
NORTH CHICAGO, Illinois, June 26, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today 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 active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy.
HS is a painful, chronic inflammatory skin disease estimated to impact approximately 1 percent of the adult population worldwide.1,2 If granted marketing authorization by the European Commission, HUMIRA will become the first and only medication approved for HS.
"The positive opinion from the CHMP is a significant milestone for people with HS in Europe because it represents progress toward the first and only approved medicine for this devastating disease," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "If approved, HUMIRA could offer new hope to people impacted by moderate to severe HS, and this demonstrates AbbVie's ongoing commitment to innovation with HUMIRA to provide new solutions for difficult-to-treat diseases."
The positive opinion is based on the results of two pivotal Phase 3 studies, PIONEER I and PIONEER II. These studies demonstrated that moderate to severe HS patients treated with HUMIRA 40 mg weekly starting at Week 4 following 160 mg at Week 0 and 80 mg at Week 2 achieved a significantly greater response versus those on placebo at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure.3-4 This is defined as at least 50 percent reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.3-4 Additionally, at Week 12, a significantly higher proportion of HUMIRA treated patients in PIONEER II experienced a clinically relevant decrease in HS-related skin pain (as measured by >30% Reduction in Skin Pain) compared to those on placebo.4 No new safety signals were identified in these trials.3-4
The review of the HS application 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 850,000 patients worldwide5 across 12 globally approved indications.6-7
About Hidradenitis Suppurativa
HS, sometimes referred to as "acne inversa" by dermatologists, is a painful, chronic inflammatory skin disease estimated to impact approximately 1 percent of the adult population worldwide.1,2 It is characterized by recurrent, painful abscesses and nodules typically located around the armpits and groin, on the buttocks and under the breasts. These symptoms may lead to physical debilitation and psychological strain that impacts the lives of patients and hinders their ability to work.1-2,8-10 While not all cases of HS are progressive, some cases of HS can grow more severe. As a result, diagnosing and properly managing HS as early as possible is important.11 This can be difficult, making it important for patients to see a dermatologist who is trained to recognize the difference between HS and other skin diseases.11
HUMIRA EU Therapeutic Indications6
HUMIRA is approved for use in adults with moderate to severe 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 and moderately to severely active ulcerative colitis. HUMIRA is approved for use in paediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, severe active Crohn's disease, and active polyarticular juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy. See Summary of product characteristics (SmPC) for full indication.
Important EU Safety Information6
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)
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.
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.
- Dufour DN, Emtestam L, Jemec GB. Hidradenitis Suppurativa: A Common and Burdensome, Yet Under-Recognised, Inflammatory Skin Disease. Postgrad Med J. 2014; 90 (1062):216-21.
- Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
- Safety and Efficacy of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from First 12 Weeks of PIONEER I, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract #210 44th Annual Meeting of the European Society for Dermatological Research (ESDR), Copenhagen, Denmark 2014.
- Efficacy and Safety of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from PIONEER II, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract FC08.2. 22nd Congress of the European Dermatology and Venereology (EADV) Meeting, Amsterdam, Netherlands 2014.
- AbbVie Data on File.
- HUMIRA [summary of product characteristics]. AbbVie Inc.; May 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Accessed June 9, 2015.
- Pharmaceutical and Medical Devices Agency (PMDA) website. New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1?. Accessed June 9, 2015.
- Mayo Health Clinic. Hidradenitis Suppurativa. Available at: http://www.mayoclinic.org/diseases-conditions/hidradenitis-suppurativa/basics/definition/con-20027334 Published April 9, 2013. Accessed June 9, 2015.
- Esmann S, Jemec GB. Psychosocial impact of hidradenitis suppurativa: a qualitative study. Acta dermato-venereologica 2011;91(3):328-332.
- Shavit E, Dreiher j, Freud T, Halevy S, Vinker S, Cohen AD. Psychiatric comorbidities in 3207 patients with hidradenitis suppurativa.JEADV.2014:1-5.
- American Academy of Dermatology. Hidradenitis suppurativa. Available at: http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/e---h/hidradenitis-suppurativa. Accessed June 9, 2015.