AbbVie and Eisai Announce the Launch of HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL
June 20 2018 - 9:51PM
JCN Newswire (English)
AbbVie GK and Eisai Co., Ltd. announced that HUMIRA for
Subcutaneous Injection 20 mg Syringe 0.2 mL, a new pediatric
formulation of HUMIRA (generic name: adalimumab [recombinant]), a
fully human anti-TNF-alpha monoclonal antibody formulation, has
been launched today after being listed in the National Health
Insurance reimbursement price list on June 15.
HUMIRA has an indication of "treatment of polyarticular juvenile
idiopathic arthritis (JIA)" that develops in pediatric
patients.
HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is a
higher-concentration formulation, which is produced by removing
some excipients, and has the same active ingredient as that of,
HUMIRA for Subcutaneous Injection 20 mg Syringe 0.4 mL that has
been commercially available since September 2011. It has also the
same formulation and concentration as those of HUMIRA for
Subcutaneous Injection 40 mg Syringe 0.4 mL and HUMIRA for
Subcutaneous Injection 80 mg Syringe 0.8 mL that were launched in
November 2016. Outside of Japan, two phase 2, randomized, single-
blind, two-period crossover studies were conducted with HUMIRA for
Subcutaneous Injection 40 mg Syringe 0.4 mL, to compare injected
site-related pain between this higher- concentration formulation
and the former formulation, using a visual analog scale (VAS).
Patients with rheumatoid arthritis showed a significantly lower VAS
pain score after injection of the higher- concentration
formulation, as compared with the former formulation.
JIA is an autoimmune disease that generally affects children under
16 years of age and is an umbrella term used to define a group of
conditions occurring among children that include some form of
chronic arthritis. In Japan, JIA affects 10-15 persons per 100,000
children, and is designated as an incurable disease by the Ministry
of Health, Labour and Welfare. Polyarticular JIA is a type of JIA
which involves five or more joints. Symptoms include painful and
swollen joints, limping, morning stiffness, decreased activity and
the reluctance to use an arm or leg.
AbbVie and Eisai will continue to promote and provide information
on the proper use of HUMIRA while making further contributions to
improve the quality of life of patients including children.
About HUMIRA
HUMIRA is a fully human anti-TNF-alpha monoclonal antibody
formulation. In Japan, it is approved for the indications of "the
treatment of rheumatoid arthritis (including inhibition of the
progression of structural damage), the treatment of plaque
psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing
spondylitis, polyarticular juvenile idiopathic arthritis*,
intestinal Behcet's disease, and non-infectious uveitis, posterior
uveitis or panuveitis, induction and maintenance therapy for
moderate to severely active Crohn's disease (limited to patients
who have had an inadequate response to conventional therapy), and
treatment of moderate to severe ulcerative colitis (limited to
patients who have had an inadequate response to conventional
therapy ).
*HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA
for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved
for this indication.
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company
committed to developing innovative advanced therapies for some of
the world's most complex and critical conditions. The company's
mission is to use its expertise, dedicated people and unique
approach to innovation to markedly improve treatments across four
primary therapeutic areas: immunology, oncology, virology and
neuroscience. In more than 75 countries, AbbVie employees are
working every day to advance health solutions for people around the
world. For more information about AbbVie, please visit us at
www.abbvie.com.
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Eisai focuses its efforts in three
therapeutic areas: integrative neuroscience, including neurology
and psychiatric medicines; integrative oncology, which encompasses
oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of
research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide healthcare system. For more information about Eisai Co.,
Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Affairs Division
AbbVie GK Public Relations Department
+81-(0)3-4577-1112
Eisai Co., Ltd.
+81-(0)3-3817-5120
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