- 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
- 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.
- 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.
- 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.
- 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 July 16, 2015.
- 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 July 16, 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
July 16, 2015.