July 30, 2015

HUMIRA® (Adalimumab) Approved by European Commission for Moderate to Severe Hidradenitis Suppurativa (HS)

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- Decision marks first and only medication approved for adults with hidradenitis suppurativa (HS)

- HS is a painful, chronic inflammatory skin disease estimated to impact 1 percent of the adult population worldwide

NORTH CHICAGO, Illinois, July 30, 2015 /PRNewswire/ --  AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that HUMIRA® (adalimumab) is approved for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment. HUMIRA is now the first and only medication approved for HS in the European Union.

HS, sometimes referred to as "acne inversa" by dermatologists, is a painful, chronic inflammatory skin disease. It is estimated to impact 1 percent of the adult population worldwide, but prevalence numbers vary across countries.1-3 It is characterized by recurrent, painful abscesses and nodules on the skin - typically around the armpits and groin, on the buttocks and under the breasts.1-2 HS can have considerable impact on patients' daily lives, their work ability, physical activities and emotional state.1-2, 4-6

"HS patients often experience painful and embarrassing symptoms that can have a detrimental impact on their lives," said Errol Prens, M.D., Ph.D., professor, Erasmus Medical Center. "HUMIRA is the first approved, well-documented treatment shown to reduce HS symptoms including pain, marking an important advancement in the management of HS."

HS can be progressive in some people, and surgery may be considered to remove skin affected by the disease in advanced stages.4 Therefore, diagnosing and managing the disease early is important.7 This can be difficult, and many people with HS experience a lengthy delay in diagnosis and treatment.1-2 It's important for HS patients and people who think they may have HS to see a dermatologist who is trained to recognize and manage the disease.7

"The approval of HUMIRA is a critical milestone in the lives of people with HS who, up until this point, had no approved treatments," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This approval represents the 13th global indication for HUMIRA, and demonstrates our commitment to advancing care for patients with serious immune-mediated conditions."

The marketing authorization is based on the results of two 36-week, two-period pivotal Phase 3 studies in 633 people with moderate to severe HS, PIONEER I and PIONEER II. Patients in these studies were randomly assigned to receive either HUMIRA or placebo in addition to daily use of topical antiseptic. Both studies showed that patients given HUMIRA had greater reductions in the numbers of abscesses and inflammatory nodules than patients given placebo. No new safety signals were identified in these trials.8-9 Additionally, at week 12, a significantly higher proportion of patients given HUMIRA in PIONEER II experienced a clinically relevant decrease in HS-related skin pain compared to those given placebo.9 More information on PIONEER I and PIONEER II is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233, respectively).

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 worldwide10 across 13 globally approved indications.11-12

HUMIRA EU Therapeutic Indications11
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, moderately to severely active ulcerative colitis and active moderate to severe hidradenitis suppurativa. 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 Information11
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. 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," 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. 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.
  2. Jemec G.  Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
  3. Vazquez BG, Alikhan A, Weaver AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013;133(1):97-103.
  4. Mayo Health Clinic. Hidradenitis Suppurativa. Available at: http://www.mayoclinic.org/diseases-conditions/hidradenitis-suppurativa/basics/definition/con-20027334. Published April 9, 2013. Accessed July 16, 2015.
  5. Esmann S, Jemec GB. Psychosocial impact of hidradenitis suppurativa: a qualitative study. Acta dermato-venereologica. 2011;91(3):328-332.
  6. Shavit E, Dreiher j, Freud T, Halevy S, Vinker S, Cohen AD. Psychiatric comorbidities in 3207 patients with hidradenitis suppurativa. JEADV.2014:1-5.
  7. American Academy of Dermatology. Hidradenitis suppurativa. Available at: http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/e---h/hidradenitis-suppurativa. Accessed July 16, 2015.
  8. 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.
  9. 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.
  10. AbbVie Data on File.
  11. 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 July 16, 2015. 
  12. 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 July 16, 2015.

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