September 27, 2021
AbbVie GK
Eisai Co., Ltd.
EA Pharma Co., Ltd.

Fully Human Anti-TNFα Monoclonal Antibody HUMIRA ®
Obtains Additional Approval for High-Dose Regimen of Ulcerative Colitis in
Adult Patients and for New Regimen in Pediatric Patients

AbbVie GK (Headquarters: Tokyo, President: James Feliciano, "AbbVie"), Eisai Co., Ltd.
(Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), and EA Pharma Co., Ltd. (Headquarters:Tokyo, CEO: Yuji Matsue, "EA Pharma") announced today the additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatricpatients regarding fully Human Anti-TNFα Monoclonal Antibody HUMIRA® (generic name,adalimumab [recombinant]; “HUMIRA”) .
This approval allows for 40 mg weekly treatment or 80 mg biweekly treatment inaddition to conventional 40 mg biweekly treatment as a remission maintenance therapy,
which is expected to maintain remission in many patients. Furthermore, by having been
added as a treatment option for ulcerative colitis in pediatric patients, it is expected thatas the first at-home/self-injectable drug in Japan for pediatric patients with ulcerative
colitis, HUMIRA will improve convenience for pediatric patients and their guardians inaddition to reducing burdens due to hospital visits.
Ulcerative colitis (UC) is designated as an intractable disease in Japan. It ischaracterized by intestinal inflammation of unknown cause and subsequent damage tothe colonic mucosa that results in erosion (a sore lesion) or ulceration. Patients withUC experience chronic diarrhea and hematochezia, abdominal pain, fever, anemia, etc.
These symptoms resolve (remission) and flare up (relapse) repeatedly. It remains along-term condition that is not adequately controlled in some patients; more treatment
options are needed. 1,2 Although the etiology of UC is still unclear, it may be associatedwith abnormalities in the immune system that protects the body from bacteria and otherforeign substances. About 220,000 people suffer from UC in Japan and the number isincreasing year by year. 3 Many patients receive a diagnosis of UC in their late 10s to
early 30s. The disease rarely develops in childhood, with an estimated prevalence inJapan of 15 per 100,000 between the ages of 0 to 19. 4
In both adults and pediatric patients, the goal of treatment for UC is achieving longterm maintenance of remission with drug treatment. However, total colectomy may
eventually be required in 30% of patients with severe UC. 5

In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA.
Abbvie and Eisai are co-promoting HUMIRA for the indications in the fields of rheumatoid
arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, juvenile idiopathic
arthritis, uveitis, pustular psoriasis, hidradenitis suppurativa and pyoderma gangrenosum.
For the indications in the field of gastrointestinal disease (i.e., Crohn’s disease, intestinal
Bechet’s disease and ulcerative colitis), AbbVie is co-promoting HUMIRA with EA Pharma,
commissioned by Eisai for promotion.
AbbVie, Eisai and EA Pharma are committed to make a further contribution totreatment for patients with autoimmune diseases through providing more treatment
options to adult and pediatric patients with UC.

Notes to editors
About HUMIRA
HUMIRA® is a fully human anti-TNF-α monoclonal antibody. In Japan, it is approved for “thetreatment of rheumatoid arthritis (including inhibition of the progression of structuraldamage); hidradenitis suppurativa, pyoderma gangrenosum, the treatment of plaquepsoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile
idiopathic arthritis,*1 intestinal Behçet's disease, and non-infectious intermediate, posterior
and panuveitis that are refractory to the conventional therapies, induction and maintenancetherapy for moderate to severely active Crohn's disease (limited to patients who have had aninadequate response to conventional therapy), and treatment of moderate to severe
ulcerative colitis*2 (limited to patients who have had an inadequate response to conventionaltherapy ).”*1

HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is approved. 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*2

HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is approved only for pediatric patients.

Nonproprietary name: Adalimumab <recombinant>Brand name: Fully Human Anti-TNF-α Monoclonal Antibody “HUMIRA for SubcutaneousInjection 20 mg Syringe 0.2 mL; HUMIRA for Subcutaneous Injection 40 mg
Syringe 0.4 mL; HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL;
HUMIRA for Subcutaneous Injection 40 mg Pen 0.4 mL; and HUMIRA for
Subcutaneous Injection 80 mg Pen 0.8 mL”
Details of the above approval (Underlined text indicates newly approved dosage andadministration)
Dosage and administration (only the section of UC is excerpted.)
Adults:The usual initial dose of adalimumab (recombinant) is 160 mg administered bysubcutaneous injection, which is followed by 80 mg administered 2 weeks after the initialdose. After 4 weeks of the initial dose, 40 mg of adalimumab is subcutaneously injectedonce every 2 weeks. However, after 4 weeks of the initial dose, adalimumab can besubcutaneously injected at 40 mg once weekly or at 80 mg once every 2 weeks,
depending on the patient’s condition.
Pediatric patients:
For pediatric patients weighing 40 kg or more, the usual initial dose of adalimumab(recombinant) is 160 mg administered by subcutaneous injection, which is followed by 80
mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initialdose, adalimumab is subcutaneously injected at 40 mg once weekly or at 80 mg once
every 2 weeks.
For pediatric patients weighing 25 kg or more and less than 40 kg, the usual initial doseof adalimumab (recombinant) is 80 mg administered by subcutaneous injection, which isfollowed by 40 mg administered 1 week and 2 weeks after the initial dose. After 4 weeksof the initial dose, adalimumab is subcutaneously injected at 20 mg once weekly or at 40
mg once every 2 weeks.
For pediatric patients weighing 15 kg or more and less than 25 kg, the usual initial doseof adalimumab (recombinant) is 40 mg administered by subcutaneous injection, which isfollowed by 20 mg administered 1 week and 2 weeks after the initial dose. After 4 weeksof the initial dose, adalimumab is subcutaneously injected at 20 mg every 2 weeks.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious healthissues today and address the medical challenges of tomorrow. We strive to have aremarkable impact on people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and gastroenterology, inaddition to products and services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter,Facebook, Instagram, YouTube and LinkedIn.

About Eisai
Eisai Co., Ltd. is a leading global research and development-based pharmaceuticalcompany headquartered in Japan. We define our corporate mission as "giving first thought
to patients and their families and to increasing the benefits health care provides," which wecall our human health care (hhc) philosophy. With approximately 10,000 employees working
across our global network of R&D facilities, manufacturing sites and marketing subsidiaries,
we strive to realize our hhc philosophy by delivering innovative products to address unmet
medical needs, with a particular focus in our strategic areas of Neurology and Oncology. For
more information about Eisai Co., Ltd., please visit www.eisai.com.

About EA Pharma
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, wasestablished in April 2016 by integration of the gastrointestinal business unit with more than
60 year’s history of the Eisai Group and the gastrointestinal business unit of the AjinomotoGroup having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal
specialty pharmaceutical company with a full value chain covering R&D, production &logistics and sales & marketing.
For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/en.

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Australian Crohn's and Colitis Association (ACCA). The Economic Costs of Crohn's Disease andUlcerative Colitis. 2007 Jun.
Romano C, Syed S, Valenti S, Kugathasan S. Management of acute severe colitis in children withulcerative colitis in the biologics era. Pediatrics. 2016 May; 137(5):e20151184. doi:
10.1542/peds.2015-1184.
Research committee of inflammatory bowel disease, Research program on rare and intractablediseases, Health, Labour and Welfare Sciences Research Grants. For the patients of ulcerative
colitis, the basic knowledge of treatments. Revised in 2020, March.
Ishige T, Tomomasa T, Hatori R, et al. Temporal trend of pediatric inflammatory bowel disease:analysis of national registry data 2004 to 2013 in Japan. J Pediatr Gastroenterol Nutr. 2017;
65(4):e80-e2.
Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative
colitis. Dis Mon. 2019 Dec; 65(12):100851.

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